Peripheral Arterial DiseaseNCT01609296
IN.PACT Global Clinical Study
A study testing IN.PACT Admiral™ Drug Eluting Balloon in people with Peripheral Arterial Disease, run by Medtronic Endovascular at 65 sites in 27 countries.
Trial summary
The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- IN.PACT Admiral™ Drug Eluting Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,535 participants
- Where
- 65 sitesin 27 countries
- Study dates
- May 2012to 17 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
General inclusion Criteria:
- Age ≥ 18 years or minimum age as required by local regulations.
- Subject with documented diagnosis of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and/or popliteal artery (PA) (including P1, P2, P3) classified as Rutherford class 2-3-4.
- Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis) within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days.
General exclusion Criteria:
- High probability of non-adherence to Clinical Investigation Protocol follow-up requirements.
- Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).
- Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.
Trial locations and contacts
65 sites in 27 countries.
65 sites in 27 countries
Germany9 sites
Herzzentrum Bad Krozingen
Bad Krozingen, 79189
Augusta Krankenhaus
Düsseldorf, 40472
Augusta-Krankenhaus
Düsseldorf
Universitätsklinikum Heidelberg
Heidelberg, 69120
Universitatsklinikum Leipzig AoR
Leipzig, 04103
Park-Krankenhaus Leipzig
Leipzig, 04289
St. Franziskus Hospital GmbH
Münster, 48145
RoMed Klinikum Rosenheim
Rosenheim, 83022
Universitätsklinikum Tübingen
Tübingen, 72076
Belgium7 sites
Onze-Lieve-Vrouwziekenuis
Aalst, 9300
Imelda Ziekenhuis
Bonheiden, 2820
AZ St. Blasius
Dendermonde, 9200
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Ziekenhuis Oost Limburg - Campus St.-Jan
Genk, 3600
Universitair Ziekenhuis Gent
Ghent, 9000
Regionaal Ziekenhuis Heilig Hart
Tienen, 3300
Netherlands5 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223GZ
Rijnstate Ziekenhuis
Arnhem, 6800TA
Catharina Ziekenhuis
Eindhoven, 5623EJ
Sint Antonius Hospital
Nieuwegein, 3430EM
Universitair Medisch Centrum Utrecht
Utrecht, 3584CX
South Korea5 sites
Severence Hospital
Seoul, 120-752
Samsung Medical Center
Seoul, 135-710
Asan Medical Center
Seoul, 138-736
Korea University Guro Hospital
Seoul, 152-703
Ajou University Hospital
Suwon, 443-380
Italy3 sites
Policlinico Vittorio Emanuele
Catania, 95123
Maria Eleonora Hospital
Palermo, 90135
Policlinico Gemelli
Rome, 00168
Slovakia3 sites
Stredoslovensky ustav srdcovych a cievnych chorob (SUSCCH)
Banská Bystrica, 97401
Národný ústav srdcových a cievnych chorôb a.s. (NUSCH)
Bratislava, 83348
Východoslovenský ústav srdcových a cievnych chorôb, a.s.(VUSH)
Košice, 04011
Switzerland3 sites
Inselspital - Universitätsspial Bern
Bern, 3010
Hopital Cantonal HFR
Fribourg, 1708
Kantonspital Luzern
Lucerne, 6000
Argentina2 sites
Fundación Favaloro
Buenos Aires
Clinica La Sagrada Familia
Bueos Aires
Austria2 sites
Medizinische Universität Graz
Graz, 8036
Landesklinikum Thermenregion Mödling
Mödling, 2340
Canada2 sites
Centre hospitalier universitaire Sherbrooke (CHUS)
Sherbrooke
Toronto General Hospital
Toronto
France2 sites
Group Hospitalier Pellegrin - CHU
Bordeaux, 33076
Les Hospitaux Universitaires de Strasbourg
Strasbourg, 67000
Hungary2 sites
Semmelweis University
Budapest, 1122
Bacs Kiskun Megyei Korhaz
Kecskemét, 6000
Israel2 sites
Carmel Medical Centre
Haifa, 34362
Rabin Medical Center - Beilison Hospital
Petah Tikva, 49100
Poland2 sites
Euromedic Medical Center
Katowice, 40-519
Samodzielny Publiczny Szpital Kliniczny Nr 2
Szczecin, 70-111
United Kingdom2 sites
Manchester Royal Infirmary
Manchester, M139WL
Northern General Hospital
Sheffield, S57AU
About this study
Official title: The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon.
The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.
Read the detailed description
Peripheral artery disease (PAD) commonly results from progressive narrowing of the arteries in the lower extremities, usually due to atherosclerosis. Progression of PAD can result in critical limb ischemia (CLI), manifested by ischemic pain at rest or in the breakdown of the skin, resulting in ulcers or gangrene which ultimately may lead to amputation and death.
The IN.PACT Global Clinical Study aims to expand and understand the safety and efficacy data on the IN.PACT Admiral™ DEB in a real world population of subjects with intermittent claudication and/or rest pain (Rutherford class 2-3-4) due to obstructive disease of the superficial femoral and/or popliteal arteries.
- Conditions
- Peripheral Arterial Disease
- Being tested
- IN.PACT Admiral™ Drug Eluting Balloon
- Keywords
- Peripheral Arterial Disease, Drug coated balloon, Superficial Femoral Artery, Popliteal Femoral Artery, Atherosclerosis, Drug eluting balloon
- Medical subject headings
- Peripheral Arterial Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN.PACT Admiral™ Drug Eluting BalloonDevice
IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon.
| Study group | Role | What they receive |
|---|---|---|
| IN.PACT Admiral DEB | Experimental | The subjects in this trial will be treated with the IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon (hereinafter referred as "IN.PACT Admiral™ DEB")manufactured by Medtronic. The IN.PACT Admiral™ is a CE (Conformité Europeénne, European Confirmity) marked medical device utilized within its intended use in the IN.PACT Global trial. Receives: Device: IN.PACT Admiral™ Drug Eluting Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cohort ITT - Primary Effectiveness Endpoint
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 12 months
Clinical Cohort ITT - Primary Safety Endpoint
A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure.
Measured: 12 months
Imaging Cohort ITT - Primary Effectiveness Endpoint
Primary Patency within 12 months post-index procedure, which is defined as:
- Freedom from clinically-driven TLR and
- Freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) ≤ 2.4.
- Restenosis determined by either PSVR >2.4 as assessed by an independent DUS core lab or >50% stenosis as assessed by an independent angiographic core lab.
Measured: 12 months
150mm DEB ITT Cohort - Primary Effectiveness Endpoint
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as:
- Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 12 months
Secondary outcomes (146)
Clinical Cohort ITT - MAEs
MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR (Target Vessel Revascularization), major target limb amputation, thrombosis at the target lesion site.
Measured: 12 months
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Measured: 12 months
Clinical Cohort ITT - TVR
Any Target vessel revascularisation
Measured: 12 months.
Clinical Cohort ITT - Device Success
Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
Measured: Index-procedure
Clinical Cohort ITT - Clinical Success
Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge
Measured: prior to discharge
Clinical Cohort ITT - MAEs
MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Measured: 60 months
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 60 months
Clinical Cohort ITT - TVR
Measured: 60 months
Clinical Cohort ITT - TLR
Measured: 60 months
Clinical Cohort ITT - Time to First Clinically-driven TLR (Days)
Measured: 60 months
Clinical Cohort ITT - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.
Measured: 30 days
Clinical Cohort ITT - MAEs
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site
Measured: 6 Months
Clinical Cohort ITT - MAEs
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Measured: 24 Months
Clinical Cohort ITT - MAEs
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Measured: 36 Months
Clinical Cohort ITT - MAEs
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Measured: 48 Months
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 30 days
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 6 Months
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 24 Months
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 36 Months
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 48 Months
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Measured: 6 Months
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Measured: 24 Months
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Measured: 36 Months
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Measured: 48 Months
Clinical Cohort ITT - TVR
Any Target lesion revascularisation
Measured: 24 Months
Clinical Cohort ITT - TVR
Any Target lesion revascularisation
Measured: 36 Months
Clinical Cohort ITT - TVR
Any Target lesion revascularisation
Measured: 48 Months
Clinical Cohort ITT - TVR
Any Target lesion revascularisation
Measured: 6 Months
Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure.
All-cause mortality is reported by using the survival estimate of all cause mortality through 60 months
Measured: 60 months
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Measured: 6 Months
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Measured: 12 Months
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Measured: 24 Months
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Measured: 36 Months
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 6 Months
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 12 Months
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 24 Months
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 36 Months
Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure
Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9
Measured: Post procedure
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 6 Months
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 12 Months
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 24 Months
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 36 Months
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Measured: 6 Months
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Measured: 12 Months
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Measured: 24 Months
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Measured: 36 Months
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Measured: 6 Months
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Measured: 12 Months
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Measured: 24 Months
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Measured: 36 Months
Clinical Cohort ITT - Procedural Success
Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate
Measured: at procedure
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion
Measured: at 12 months, or at the time of re-intervention
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion
Measured: At 12 months, or at the time of re-intervention
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.
Measured: 30 days
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 6 months.
Measured: 6 months
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 12 months.
Measured: 12 months
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 24 months.
Measured: 24 months
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 36 months.
Measured: 36 months
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 48 months.
Measured: 48 months
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 60 months.
Measured: 60 months
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 30 days
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 6 months
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 24 months
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 36 months
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 48 months
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 60 months
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
Measured: 6 Months
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
Measured: 12 Months
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
Measured: 24 Months
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
Measured: 36 Months
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
Measured: 48 Months
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
Measured: 60 Months
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
Measured: 6 Months
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
Measured: 12 Months
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
Measured: 24 Months
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
Measured: 36 Months
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
Measured: 48 Months
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
Measured: 60 Months
150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days)
Measured: 60 months
150mm DEB ITT Cohort - Time to All-cause Mortality Through 60 Months Post-index Procedure.
All-cause mortality is reported by using the survival estimate of all-cause mortality through 60 months
Measured: 60 months
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 6 months.
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 12 months.
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 24 months
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 36 months
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 6 Months
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 12 Months
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 24 Months
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 36 Months
150mm DEB ITT Cohort - Immediate Hemodynamic Improvement at Post-index Procedure
Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9
Measured: Post procedure
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 6 Months
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 12 Months
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 24 Months
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Measured: 36 Months
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Measured: 6 Months
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Measured: 12 Months
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Measured: 24 Months
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Measured: 36 Months
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Measured: 6 Months
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Measured: 12 Months
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Measured: 24 Months
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Measured: 36 Months
150mm DEB ITT Cohort - Device Success
Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
Measured: Index-procedure
150mm DEB ITT Cohort - Procedural Success
Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate
Measured: at procedure
150mm DEB ITT Cohort - Clinical Success
Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge
Measured: prior to discharge
Clinical Cohort ITT - All-cause Mortality
Measured: 30 days
Clinical Cohort ITT - All-cause Mortality
Measured: 6 Months
Clinical Cohort ITT - All-cause Mortality
Measured: 12 Months
Clinical Cohort ITT - All-cause Mortality
Measured: 24 Months
Clinical Cohort ITT - All-cause Mortality
Measured: 36 Months
Clinical Cohort ITT - All-cause Mortality
Measured: 48 Months
Clinical Cohort ITT - All-cause Mortality
The difference in death count calculation between the compliance table (participant flow: 253 deaths) and the event table (244 deaths) is explained as follow:
- Calendar days (365/year) is used for compliance table whereas 360-day annual cutoff is used for event rate calculation
- Compliance table used visit window as specified by protocol (60 days for 5-year follow-up) whereas, not window is used for event rate calculation
- Nine patients died between 1801 and 1885 (1825 + 60) and were therefore not included in the 5-year death rate summary but were included in the compliance summary for patients that died through the upper window of the 60 month visit.
- The denominator of 1215 for 1800-day event rate includes those who had an event within 1800 days and those who did not have any event but had at least 1740 days of follow-up (1740 is the low bound of the 60-day visit window from the target day of 1800)
Measured: 60 Months
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 30 days
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 6 Months
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 12 Months
Clinical Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 24 Months
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 36 Months
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 48 Months
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 60 Months
Clinical Cohort ITT - Major Target Limb Amputation
Measured: 30 days
Clinical Cohort ITT - Major Target Limb Amputation
Measured: 6 Months
Clinical Cohort ITT - Major Target Limb Amputation
Measured: 12 Months
Clinical Cohort ITT - Major Target Limb Amputation
Measured: 24 Months
Clinical Cohort ITT - Major Target Limb Amputation
Measured: 36 Months
Clinical Cohort ITT - Major Target Limb Amputation
Measured: 48 Months
Clinical Cohort ITT - Major Target Limb Amputation
Measured: 60 Months
150mm DEB ITT Cohort - All-cause Mortality
Measured: 30 days
150mm DEB ITT Cohort - All-cause Mortality
Measured: 6 Months
150mm DEB ITT Cohort - All-cause Mortality
Measured: 12 Months
150mm DEB ITT Cohort - All-cause Mortality
Measured: 24 Months
150mm DEB ITT Cohort - All-cause Mortality
Measured: 36 Months
150mm DEB ITT Cohort - All-cause Mortality
Measured: 48 Months
150mm DEB ITT Cohort - All-cause Mortality
Measured: 60 Months
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 30 days
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 6 Months
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 12 Months
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 24 Months
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 36 Months
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 48 Months
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Measured: 60 Months
150mm DEB ITT Cohort - Major Target Limb Amputation
Measured: 30 days
150mm DEB ITT Cohort - Major Target Limb Amputation
Measured: 6 Months
150mm DEB ITT Cohort - Major Target Limb Amputation
Measured: 12 Months
150mm DEB ITT Cohort - Major Target Limb Amputation
Measured: 24 Months
150mm DEB ITT Cohort - Major Target Limb Amputation
Measured: 36 Months
150mm DEB ITT Cohort - Major Target Limb Amputation
Measured: 48 Months
150mm DEB ITT Cohort - Major Target Limb Amputation
Measured: 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startMay 2012
- Primary completionApr 2016
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gunnar Tepe, MD, Principal investigator, Klinikum RosenheimGary Ansel, MD, Principal investigator, MidOhio Cardiology and Vascular ConsultantsMarc Bosiers, MD, Principal investigator, AZ Sint BlasiusDo-Dai Do, MD, Principal investigator, Swiss Cardiovascular Center, InselspitalPeter Gaines, MD, Principal investigator, Sheffield Vascular InstituteAlvaro Razuk, MD, Principal investigator, Faculdade de Ciências Médicas da Santa Casa de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609296
- Sponsor's protocol ID
- 10048613
- Status last verified
- Feb 2021
- First submitted
- 24 May 2012
- Last updated
- 25 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ansel GM, Brodmann M, Rocha-Singh KJ, Menk JS, Zeller T; IN.PACT Global Study Investigators. Five-Year Safety and Effectiveness of Paclitaxel Drug-Coated Balloons Alone or With Provisional Bare Metal Stenting for Real-World Femoropopliteal Lesions: IN.PACT Global Study Subgroup Analysis. Circ Cardiovasc Interv. 2024 Feb;17(2):e013084. doi: 10.1161/CIRCINTERVENTIONS.123.013084. Epub 2024 Feb 13.
PubMed 38348677Krishnan P, Farhan S, Schneider P, Kamran H, Iida O, Brodmann M, Micari A, Sachar R, Urasawa K, Scheinert D, Ando K, Tarricone A, Doros G, Tepe G, Yokoi H, Laird J, Zeller T. Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. J Am Coll Cardiol. 2022 Sep 27;80(13):1241-1250. doi: 10.1016/j.jacc.2022.06.043.
PubMed 36137674Brodmann M, Lansink W, Guetl K, Micari A, Menk J, Zeller T. Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study. Cardiovasc Intervent Radiol. 2022 Sep;45(9):1276-1287. doi: 10.1007/s00270-022-03214-y. Epub 2022 Jul 21.
PubMed 35864209Zeller T, Brodmann M, Ansel GM, Scheinert D, Choi D, Tepe G, Menk J, Micari A. Paclitaxel-coated balloons for femoropopliteal peripheral arterial disease: final five-year results of the IN.PACT Global Study. EuroIntervention. 2022 Dec 2;18(11):e940-e948. doi: 10.4244/EIJ-D-21-01098.
PubMed 35635160Torsello G, Stavroulakis K, Brodmann M, Micari A, Tepe G, Veroux P, Benko A, Choi D, Vermassen FEG, Jaff MR, Guo J, Dobranszki R, Zeller T; IN.PACT Global Investigators. Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort. J Endovasc Ther. 2020 Oct;27(5):693-705. doi: 10.1177/1526602820931477. Epub 2020 Jun 25.
PubMed 32583749Shishehbor MH, Schneider PA, Zeller T, Razavi MK, Laird JR, Wang H, Tieche C, Parikh SA, Iida O, Jaff MR. Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts. J Vasc Surg. 2019 Oct;70(4):1177-1191.e9. doi: 10.1016/j.jvs.2019.02.030.
PubMed 31543165Reijnen MMPJ, van Wijck I, Zeller T, Micari A, Veroux P, Keirse K, Lee SW, Li P, Voulgaraki D, Holewijn S. Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study. J Endovasc Ther. 2019 Jun;26(3):305-315. doi: 10.1177/1526602819839044. Epub 2019 Apr 1.
PubMed 30931726Tepe G, Micari A, Keirse K, Zeller T, Scheinert D, Li P, Schmahl R, Jaff MR; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The Chronic Total Occlusion Cohort in the IN.PACT Global Study. JACC Cardiovasc Interv. 2019 Mar 11;12(5):484-493. doi: 10.1016/j.jcin.2018.12.004.
PubMed 30846089Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon. J Am Coll Cardiol. 2019 May 28;73(20):2550-2563. doi: 10.1016/j.jacc.2019.01.013. Epub 2019 Jan 25.
PubMed 30690141Zeller T, Brodmann M, Micari A, Keirse K, Peeters P, Tepe G, Scheinert D, Jaff MR, Rocha-Singh KJ, Li P, Schmahl R, Ansel GM; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain. Circ Cardiovasc Interv. 2019 Jan;12(1):e007730. doi: 10.1161/CIRCINTERVENTIONS.118.007730. No abstract available.
PubMed 30630355Banerjee S, Khalili H. Drug-Coated Balloon for Long Femoropopliteal Lesions. Circ Cardiovasc Interv. 2018 Oct;11(10):e007084. doi: 10.1161/CIRCINTERVENTIONS.118.007084. No abstract available.
PubMed 30354645Scheinert D, Micari A, Brodmann M, Tepe G, Peeters P, Jaff MR, Wang H, Schmahl R, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease. Circ Cardiovasc Interv. 2018 Oct;11(10):e005654. doi: 10.1161/CIRCINTERVENTIONS.117.005654.
PubMed 30354636Ansel GM, Brodmann M, Keirse K, Micari A, Jaff MR, Rocha-Singh K, Fernandez EJ, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study. J Endovasc Ther. 2018 Dec;25(6):673-682. doi: 10.1177/1526602818803119. Epub 2018 Oct 3.
PubMed 30280648Micari A, Brodmann M, Keirse K, Peeters P, Tepe G, Frost M, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study. JACC Cardiovasc Interv. 2018 May 28;11(10):945-953. doi: 10.1016/j.jcin.2018.02.019.
PubMed 29798770
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon.
- ClinicalTrials.gov ID
- NCT01609296
- Acronym / sponsor ID
- 10048613
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Arterial Disease, Drug coated balloon, Superficial Femoral Artery, Popliteal Femoral Artery, Atherosclerosis, Drug eluting balloon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,535 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 31 May 2012 (estimated)
- Results
- Posted 28 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.
Detailed description
Peripheral artery disease (PAD) commonly results from progressive narrowing of the arteries in the lower extremities, usually due to atherosclerosis. Progression of PAD can result in critical limb ischemia (CLI), manifested by ischemic pain at rest or in the breakdown of the skin, resulting in ulcers or gangrene which ultimately may lead to amputation and death.
The IN.PACT Global Clinical Study aims to expand and understand the safety and efficacy data on the IN.PACT Admiral™ DEB in a real world population of subjects with intermittent claudication and/or rest pain (Rutherford class 2-3-4) due to obstructive disease of the superficial femoral and/or popliteal arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IN.PACT Admiral DEB | Experimental | Device: IN.PACT Admiral™ Drug Eluting BalloonThe subjects in this trial will be treated with the IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon (hereinafter referred as "IN.PACT Admiral™ DEB")manufactured by Medtronic. The IN.PACT Admiral™ is a CE (Conformité Europeénne, European Confirmity) marked medical device utilized within its intended use in the IN.PACT Global trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IN.PACT Admiral™ Drug Eluting BalloonIN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon. | Device | IN.PACT Admiral DEB |
Primary outcome
Clinical Cohort ITT - Primary Effectiveness Endpoint
Time frame: 12 months
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Clinical Cohort ITT - Primary Safety Endpoint
Time frame: 12 months
A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure.
Imaging Cohort ITT - Primary Effectiveness Endpoint
Time frame: 12 months
Primary Patency within 12 months post-index procedure, which is defined as: * Freedom from clinically-driven TLR and * Freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) ≤ 2.4. * Restenosis determined by either PSVR >2.4 as assessed by an independent DUS core lab or >50% stenosis as assessed by an independent angiographic core lab.
150mm DEB ITT Cohort - Primary Effectiveness Endpoint
Time frame: 12 months
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
146 secondary outcomes
Clinical Cohort ITT - MAEs
Time frame: 12 months
Clinical Cohort ITT - TLR
Time frame: 12 months
Clinical Cohort ITT - TVR
Time frame: 12 months.
Clinical Cohort ITT - Device Success
Time frame: Index-procedure
Clinical Cohort ITT - Clinical Success
Time frame: prior to discharge
Clinical Cohort ITT - MAEs
Time frame: 60 months
Clinical Cohort ITT - Clinically-driven TLR
Time frame: 60 months
Clinical Cohort ITT - TVR
Time frame: 60 months
Clinical Cohort ITT - TLR
Time frame: 60 months
Clinical Cohort ITT - Time to First Clinically-driven TLR (Days)
Time frame: 60 months
Clinical Cohort ITT - MAEs
Time frame: 30 days
Clinical Cohort ITT - MAEs
Time frame: 6 Months
Clinical Cohort ITT - MAEs
Time frame: 24 Months
Clinical Cohort ITT - MAEs
Time frame: 36 Months
Clinical Cohort ITT - MAEs
Time frame: 48 Months
Clinical Cohort ITT - Clinically-driven TLR
Time frame: 30 days
Clinical Cohort ITT - Clinically-driven TLR
Time frame: 6 Months
Clinical Cohort ITT - Clinically-driven TLR
Time frame: 24 Months
Clinical Cohort ITT - Clinically-driven TLR
Time frame: 36 Months
Clinical Cohort ITT - Clinically-driven TLR
Time frame: 48 Months
Clinical Cohort ITT - TLR
Time frame: 6 Months
Clinical Cohort ITT - TLR
Time frame: 24 Months
Clinical Cohort ITT - TLR
Time frame: 36 Months
Clinical Cohort ITT - TLR
Time frame: 48 Months
Clinical Cohort ITT - TVR
Time frame: 24 Months
Clinical Cohort ITT - TVR
Time frame: 36 Months
Clinical Cohort ITT - TVR
Time frame: 48 Months
Clinical Cohort ITT - TVR
Time frame: 6 Months
Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure.
Time frame: 60 months
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Time frame: 6 Months
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Time frame: 12 Months
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Time frame: 24 Months
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Time frame: 36 Months
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Time frame: 6 Months
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Time frame: 12 Months
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Time frame: 24 Months
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Time frame: 36 Months
Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure
Time frame: Post procedure
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Time frame: 6 Months
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38348677Ansel GM, Brodmann M, Rocha-Singh KJ, Menk JS, Zeller T; IN.PACT Global Study Investigators. Five-Year Safety and Effectiveness of Paclitaxel Drug-Coated Balloons Alone or With Provisional Bare Metal Stenting for Real-World Femoropopliteal Lesions: IN.PACT Global Study Subgroup Analysis. Circ Cardiovasc Interv. 2024 Feb;17(2):e013084. doi: 10.1161/CIRCINTERVENTIONS.123.013084. Epub 2024 Feb 13.
- Derived from this study: PubMed 36137674Krishnan P, Farhan S, Schneider P, Kamran H, Iida O, Brodmann M, Micari A, Sachar R, Urasawa K, Scheinert D, Ando K, Tarricone A, Doros G, Tepe G, Yokoi H, Laird J, Zeller T. Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. J Am Coll Cardiol. 2022 Sep 27;80(13):1241-1250. doi: 10.1016/j.jacc.2022.06.043.
- Derived from this study: PubMed 35864209Brodmann M, Lansink W, Guetl K, Micari A, Menk J, Zeller T. Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study. Cardiovasc Intervent Radiol. 2022 Sep;45(9):1276-1287. doi: 10.1007/s00270-022-03214-y. Epub 2022 Jul 21.
- Derived from this study: PubMed 35635160Zeller T, Brodmann M, Ansel GM, Scheinert D, Choi D, Tepe G, Menk J, Micari A. Paclitaxel-coated balloons for femoropopliteal peripheral arterial disease: final five-year results of the IN.PACT Global Study. EuroIntervention. 2022 Dec 2;18(11):e940-e948. doi: 10.4244/EIJ-D-21-01098.
- Derived from this study: PubMed 32583749Torsello G, Stavroulakis K, Brodmann M, Micari A, Tepe G, Veroux P, Benko A, Choi D, Vermassen FEG, Jaff MR, Guo J, Dobranszki R, Zeller T; IN.PACT Global Investigators. Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort. J Endovasc Ther. 2020 Oct;27(5):693-705. doi: 10.1177/1526602820931477. Epub 2020 Jun 25.
- Derived from this study: PubMed 31543165Shishehbor MH, Schneider PA, Zeller T, Razavi MK, Laird JR, Wang H, Tieche C, Parikh SA, Iida O, Jaff MR. Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts. J Vasc Surg. 2019 Oct;70(4):1177-1191.e9. doi: 10.1016/j.jvs.2019.02.030.
- Derived from this study: PubMed 30931726Reijnen MMPJ, van Wijck I, Zeller T, Micari A, Veroux P, Keirse K, Lee SW, Li P, Voulgaraki D, Holewijn S. Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study. J Endovasc Ther. 2019 Jun;26(3):305-315. doi: 10.1177/1526602819839044. Epub 2019 Apr 1.
- Derived from this study: PubMed 30846089Tepe G, Micari A, Keirse K, Zeller T, Scheinert D, Li P, Schmahl R, Jaff MR; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The Chronic Total Occlusion Cohort in the IN.PACT Global Study. JACC Cardiovasc Interv. 2019 Mar 11;12(5):484-493. doi: 10.1016/j.jcin.2018.12.004.
- Derived from this study: PubMed 30690141Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon. J Am Coll Cardiol. 2019 May 28;73(20):2550-2563. doi: 10.1016/j.jacc.2019.01.013. Epub 2019 Jan 25.
- Derived from this study: PubMed 30630355Zeller T, Brodmann M, Micari A, Keirse K, Peeters P, Tepe G, Scheinert D, Jaff MR, Rocha-Singh KJ, Li P, Schmahl R, Ansel GM; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain. Circ Cardiovasc Interv. 2019 Jan;12(1):e007730. doi: 10.1161/CIRCINTERVENTIONS.118.007730. No abstract available.
- Derived from this study: PubMed 30354645Banerjee S, Khalili H. Drug-Coated Balloon for Long Femoropopliteal Lesions. Circ Cardiovasc Interv. 2018 Oct;11(10):e007084. doi: 10.1161/CIRCINTERVENTIONS.118.007084. No abstract available.
- Derived from this study: PubMed 30354636Scheinert D, Micari A, Brodmann M, Tepe G, Peeters P, Jaff MR, Wang H, Schmahl R, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease. Circ Cardiovasc Interv. 2018 Oct;11(10):e005654. doi: 10.1161/CIRCINTERVENTIONS.117.005654.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Tepe, MD principal investigator
Klinikum Rosenheim
Gary Ansel, MD principal investigator
MidOhio Cardiology and Vascular Consultants
Marc Bosiers, MD principal investigator
AZ Sint Blasius
65 sites in 27 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IN.PACT Admiral™ Drug Eluting Balloon in people with Peripheral Arterial Disease, run by Medtronic Endovascular at 65 sites in 27 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in Germany, Belgium, Netherlands, South Korea, Italy and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cohort ITT - Primary Effectiveness Endpoint (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01609296, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021; AzTrials last refreshed its copy on 27 Oct 2026.