Femoral Artery OcclusionNCT02013271
Lutonix® DCB for Treatment of Long Lesions in Femoropopliteal Arteries
An observational study of Femoral Artery Occlusion and Femoral Arterial Stenosis, run by C. R. Bard at 14 sites in 5 countries.
Trial summary
To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Artery Occlusion, Femoral Arterial Stenosis
- What is being tested?
- Lutonix Paclitaxel Drug Coated Balloon (DCB)
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 14 sitesin 5 countries
- Study dates
- Dec 2013to 13 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: The study will enroll patients presenting with claudication or ischemic rest pain (Rutherford Category 2-4) and TASC II Class C or D lesions ≥14 cm in length in the native femoropopliteal artery. After successful pre-dilatation (1mm < RVD) and spot stenting (if necessary, with length minimized to mechanical defect), subjects will receive treatment with the Lutonix Drug Coated Balloon (DCB).
Who may be able to join
- Clinical Criteria
- ≥ 18 years of age;
- Rutherford Clinical Category 2-4;
- The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, is willing to provide 5-year informed consent and has duly signed the informed consent form (ICF).
- Angiographic Criteria
- Significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery (by visual estimate) that is amenable to DCB with or without stenting;
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- TASC II Class C or D Lesions with intended target lesion treatment segment(s) cumulatively ≥14 cm in length;
- de novo lesion(s) or non-stented restenotic lesion(s) > 90 days from prior angioplasty procedure;
- Proximal margin of target lesion(s) starts ≥ 1 cm below the common femoral bifurcation;
- Distal margin of target lesion(s) terminates at bifurcation of popliteal artery AND ≥1 cm above the origin of the TP trunk;
- Target vessel diameter between ≥ 4 and ≤ 7 mm and able to be treated with available device size matrix;
- A patent inflow artery free from significant lesion (≥ 50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of iliac inflow artery lesions); NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤ 30% without death or major vascular complication.
- Successful wire crossing and pre-dilatation of the target lesion; NOTE: Use of crossing devices allowed if necessary NOTE: Bare nitinol stenting of short segments (length minimized to the mechanical defect) is required after pre-dilatation to resolve flow-limiting dissections or if deemed clinically necessary.
- At least one patent native outflow artery to the ankle, free from significant (≥ 50%) stenosis as confirmed by angiography that has not previously been revascularized (treatment of outflow disease is NOT permitted during the index procedure);
- No other prior vascular interventions (including contralateral limb) within 2 weeks before and/or planned 30 days after the protocol treatment.
Who cannot join
- 1. Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children;
- Patient is contraindicated to use Lutonix Drug Coated Balloon per the current Instructions For Use (IFU)
- Life expectancy of < 1year;
- Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in an investigational device or pharmaceutical clinical trial during the follow up period is not allowed.
- History of stroke within 3 months;
- History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
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- Prior vascular surgery of the index limb, with the exception of endarterectomy or remote common femoral patch angioplasty, separated by at least 1 cm from the target lesion;
- Target lesion involves a previously placed stent
- Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication;
- No normal proximal artery segment in which duplex flow velocity can be measured;
- Significant inflow disease. Successful treatment of inflow iliac disease allowed prior to target lesion treatment;
- Unsuccessful crossing; NOTE: crossing devices allowed
- Known inadequate distal outflow (> 50% stenosis of distal popliteal or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion;
- Sudden symptom onset, acute vessel occlusion, or acute or sub-acute angiographically visible thrombus in target vessel;
- Intended use of laser, atherectomy or cryoplasty during the index procedure.
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
Germany7 sites
Ev.Krankenhaus Königin Elisabeth
Berlin, 10365
Asklepios Klinik St. Georg
Hamburg, 20099
University Clinical Center Heidelberg
Heidelberg, 69120
Westfälische Wilhelms-Universität Münster
Münster, 48149
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, 93049
Medinos Kliniken Sonneberg
Sonneberg, 96515
Universitätsklinikum Tübingen
Tübingen, 72076
Belgium4 sites
ZNA-Campus Middelheim
Antwerp, 2020
UZA Antwerp University Hospital
Edegem, 2650
Ziekenhuis Oost Limburg
Genk, 3600
AZ Groeninge
Kortrijk, 8500
Switzerland1 site
Luzerner Kantonsspital, Division of Angiology
Lucerne, 6000
About this study
Official title: A Prospective, Multicenter, Single-Arm Trial With the Lutonix Drug Coated Balloon for Treatment of Long Lesions in Femoropopliteal Arteries
To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA
Read the detailed description
The study will enroll patients presenting with claudication or ischemic rest pain (Rutherford Category 2-4) and TASC II Class C or D lesions ≥14 cm in length in the native femoropopliteal artery. After successful pre-dilatation (1mm < RVD) and spot stenting (if necessary, with length minimized to mechanical defect), subjects will receive treatment with the Lutonix Drug Coated Balloon (DCB).
The primary safety and efficacy endpoint assessments are performed at 12 months. Clinical follow-up continues through a minimum of 2 years and telephone follow-up through a minimum of 3 years.
- Being tested
- Lutonix Paclitaxel Drug Coated Balloon (DCB)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutonix Paclitaxel Drug Coated Balloon (DCB)Device
Patients exposed to the DCB as part of their routine care.
| Study group | Role | What they receive |
|---|---|---|
| Lutonix DCB | Lutonix Paclitaxel Drug Coated Balloon Receives: Device: Lutonix Paclitaxel Drug Coated Balloon (DCB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Medical Safety
Combination assessment of freedom from all-cause peri-procedural (≤30 day) death and freedom at 1 year from the following: index limb amputation (above or below the ankle) and index limb re-intervention. Success is freedom from all specified events; failure is one or more specified events occurs.
Measured: 12 Months
Primary Endpoint Efficacy, measured by presence of primary patency of the target lesion. Patency is assessed by a Corelab based on ultrasound images
Primary Patency is defined as Freedom from Clinically-Driven Target Lesion Revascularization and from Binary Restenosis. Binary restenosis is adjudicated by the independent, blinded core laboratory based on threshold Doppler PSVR ≥ 2.5 (together with wafeform analysis \& color mosaic appearance) or based on angiographic ≥ 50% diameter stenosis (if angiography is performed although not required per protocol). Clinically-Driven TLR is adjudicated by the Clincal Events Committee.
Measured: 12 Months
Secondary outcomes (18)
Secondary Endpoint Medical Safety: Major vascular complications
Major vascular complications will be counted:
- Haematoma at access site >5 cm
- False aneurysm
- AV fistula
- Retroperitoneal bleed
- Peripheral ischemia/nerve injury
- Any transfusion required will be reported as a vascular complication unless clinical indication clearly other than catheterization complication
- Vascular surgical repair
Measured: ≤30 days after index procedure
Secondary Endpoint Medical Safety: Composite Safety
Combination assessment of freedom from all-cause death and freedom from the following: index limb amputation (above or below the ankle) and index limb re-intervention. Success is freedom from all specified events; failure is one or more specified events occurs.
Measured: 1, 6, 12, 24, 36 months after index procedure
Secondary Endpoint Medical Safety: All-cause death
Death by any cause will be counted.
Measured: 1, 6, 12, 24, 36 months after index procedure
Secondary Endpoint Medical Safety: Major amputation at target limb
Amputations above the ankle of the target leg will be counted.
Measured: 1, 6, 12, 24, 36 months after index procedure
Secondary Endpoint Medical Safety: Minor amputation at target limb
Amputations below the ankle of the target leg will be counted.
Measured: 1, 6, 12, 24, 36 months after index procedure
Secondary Endpoint Medical Safety: Target Vessel Revascularization (TVR)
Repeat intervention at the target vessel will be counted.
Measured: 1, 6, 12, 24, 36 months after index procedure
Secondary Endpoint Medical Safety: Target Limb Reintervention
Repeat intervention at the target leg will be counted.
Measured: 1, 6, 12, 24, 36 months after index procedure
Secondary Endpoint Efficacy: Acute Device Success
Device success is defined as, a per device basis, the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system. If a device is inserted into the subject but not used due to user error (e.g. inappropriate balloon length or transit time too long), this device will not be included in the device success assessment.
Measured: During index procedure
Secondary Endpoint Efficacy: Technical Success
Technical Success of the balloon procedure is defined as successful access and deployment of the device and visual estimate of ≤ 30% diameter residual stenosis during the index procedure.
Measured: During index procedure
Secondary Endpoint Efficacy: Procedural Success
Attainment of ≤ 30% residual stenosis in the treatment area by independent core lab analysis without major adverse events (defined as occurrence of death, major amputation of the target limb, target vessel or distal revascularization) during the index procedure and through the hospital stay.
Measured: Until index hospitalization discharge
Secondary Endpoint Efficacy: Primary Patency
Primary Patency is defined as Freedom from Clinically-Driven Target Lesion Revascularization and from Binary Restenosis. Binary restenosis is adjudicated by the independent, blinded core laboratory based on threshold Doppler PSVR ≥ 2.5 (together with waveform analysis \& color mosaic appearance) or based on angiographic ≥ 50% diameter stenosis (if angiography is performed although not required per protocol). Clinically-Driven Target Lesion Revascularization is adjudicated by the Clinical Evenbts Committee.
Measured: 6, 12, 24, 36 months after index procedure
Secondary Endpoint Efficacy: Secondary Patency
Secondary Patency of the target lesion is defined as the absence of binary restenosis as adjudicated by the blinded, independent core laboratory, independent of whether or not patency is re-established via an endovascular procedure.
Measured: 6, 12, 24, 36 months after index procedure
Secondary Endpoint Efficacy: Clinically-driven Target Lesion Revascularization (TLR)
Revascularization of the target vessel with evidence of diameter stenosis >50% determined by duplex ultrasound or angiography and new distal ischemic signs (worsening ABI or worsening Rutherford Category associated with the target limb or due to clinical symptoms) OR revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms.
Measured: 6, 12, 24, 36 months after index procedure
Secondary Endpoint Efficacy: Target Lesion Revascularization (TLR)
A repeat revascularization procedure (percutaneous or surgical) of the original target lesion site.
Measured: 6, 12, 24, 36 months after index procedure
Secondary Endpoint Efficacy: Change of Rutherford classification from baseline
Patients are enrolled with a Rutherford grade of 2-4 for their target leg. The Rutherford scale is an indicator for the severity of Peripheral Vascular Disease: 0 = no symptoms, 6 = functional foot is no longer salvageable (leading to foot amputation).
Measured: 6, 12, 24 months after index procedure
Secondary Endpoint Efficacy: Change of resting Ankle Brachial Index (ABI) from baseline
The ABI values will be recorded and compared to the baseline values. The ABI is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. A ratio of 0.9-1.3 is in the normal range. Lower ratios indicate bad blood perfusion of the leg.
Measured: 6, 12, 24 months after index procedure
Secondary Endpoint Efficacy: Change in Walking Impairment Questionnaire from baseline
The Walking Impairment Questionnaire values will be recorded and compared to the baseline values.
This questionnaire is a validated tool to assess walking capability in patients with Peripheral Arterial Disease in different situations. Worst possible score in this study would be 0, best possible score would be 92.
Measured: 6, 12, 24 months after index procedure
Secondary Endpoint Efficacy: Change in quality of life from baseline, as measured by EQ-5D
The EQ-5D Questionnaire values will be recorded and compared to the baseline values.
It is a validated questionnaire to measure the quality of life based on 5 different paremeters. Worst possible score in this study would be 0, best possible score would be 1. In addition the patient indicates her/his current health on an analog scale from 0 (worst) to 100 (best).
Measured: 6, 12, 24 months after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startDec 2013
- Primary completion23 May 2016
- Study completion13 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Artery OcclusionStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Banyai, MD, PhD, Principal investigator, Cantonal Hospital, LucerneProf. Eric Ducasse, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013271
- Sponsor's protocol ID
- CL0017-01
- Status last verified
- Oct 2019
- First submitted
- 11 Dec 2013
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm Trial With the Lutonix Drug Coated Balloon for Treatment of Long Lesions in Femoropopliteal Arteries
- ClinicalTrials.gov ID
- NCT02013271
- Acronym / sponsor ID
- CL0017-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Dec 2013 (actual)
- Primary completion
- 23 May 2016 (actual)
- Study completion
- 13 Jun 2018 (actual)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA
Detailed description
The study will enroll patients presenting with claudication or ischemic rest pain (Rutherford Category 2-4) and TASC II Class C or D lesions ≥14 cm in length in the native femoropopliteal artery. After successful pre-dilatation (1mm < RVD) and spot stenting (if necessary, with length minimized to mechanical defect), subjects will receive treatment with the Lutonix Drug Coated Balloon (DCB).
The primary safety and efficacy endpoint assessments are performed at 12 months. Clinical follow-up continues through a minimum of 2 years and telephone follow-up through a minimum of 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lutonix DCB | – | Device: Lutonix Paclitaxel Drug Coated Balloon (DCB)Lutonix Paclitaxel Drug Coated Balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll patients presenting with claudication or ischemic rest pain (Rutherford Category 2-4) and TASC II Class C or D lesions ≥14 cm in length in the native femoropopliteal artery. After successful pre-dilatation (1mm < RVD) and spot stenting (if necessary, with length minimized to mechanical defect), subjects will receive treatment with the Lutonix Drug Coated Balloon (DCB).
Key inclusion criteria (15 listed)
- Clinical Criteria
- ≥ 18 years of age;
- Rutherford Clinical Category 2-4;
- The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, is willing to provide 5-year informed consent and has duly signed the informed consent form (ICF).
- Angiographic Criteria
Key exclusion criteria (15 listed)
- 1. Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children;
- Patient is contraindicated to use Lutonix Drug Coated Balloon per the current Instructions For Use (IFU)
- Life expectancy of < 1year;
- Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in an investigational device or pharmaceutical clinical trial during the follow up period is not allowed.
- History of stroke within 3 months;
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 |
|---|---|---|
| Lutonix Paclitaxel Drug Coated Balloon (DCB)Patients exposed to the DCB as part of their routine care. | Device | Lutonix DCB |
Primary outcome
Overall Medical Safety
Time frame: 12 Months
Combination assessment of freedom from all-cause peri-procedural (≤30 day) death and freedom at 1 year from the following: index limb amputation (above or below the ankle) and index limb re-intervention. Success is freedom from all specified events; failure is one or more specified events occurs.
Primary Endpoint Efficacy, measured by presence of primary patency of the target lesion. Patency is assessed by a Corelab based on ultrasound images
Time frame: 12 Months
Primary Patency is defined as Freedom from Clinically-Driven Target Lesion Revascularization and from Binary Restenosis. Binary restenosis is adjudicated by the independent, blinded core laboratory based on threshold Doppler PSVR ≥ 2.5 (together with wafeform analysis \& color mosaic appearance) or based on angiographic ≥ 50% diameter stenosis (if angiography is performed although not required per protocol). Clinically-Driven TLR is adjudicated by the Clincal Events Committee.
18 secondary outcomes
Secondary Endpoint Medical Safety: Major vascular complications
Time frame: ≤30 days after index procedure
Secondary Endpoint Medical Safety: Composite Safety
Time frame: 1, 6, 12, 24, 36 months after index procedure
Secondary Endpoint Medical Safety: All-cause death
Time frame: 1, 6, 12, 24, 36 months after index procedure
Secondary Endpoint Medical Safety: Major amputation at target limb
Time frame: 1, 6, 12, 24, 36 months after index procedure
Secondary Endpoint Medical Safety: Minor amputation at target limb
Time frame: 1, 6, 12, 24, 36 months after index procedure
Secondary Endpoint Medical Safety: Target Vessel Revascularization (TVR)
Time frame: 1, 6, 12, 24, 36 months after index procedure
Secondary Endpoint Medical Safety: Target Limb Reintervention
Time frame: 1, 6, 12, 24, 36 months after index procedure
Secondary Endpoint Efficacy: Acute Device Success
Time frame: During index procedure
Secondary Endpoint Efficacy: Technical Success
Time frame: During index procedure
Secondary Endpoint Efficacy: Procedural Success
Time frame: Until index hospitalization discharge
Secondary Endpoint Efficacy: Primary Patency
Time frame: 6, 12, 24, 36 months after index procedure
Secondary Endpoint Efficacy: Secondary Patency
Time frame: 6, 12, 24, 36 months after index procedure
Secondary Endpoint Efficacy: Clinically-driven Target Lesion Revascularization (TLR)
Time frame: 6, 12, 24, 36 months after index procedure
Secondary Endpoint Efficacy: Target Lesion Revascularization (TLR)
Time frame: 6, 12, 24, 36 months after index procedure
Secondary Endpoint Efficacy: Change of Rutherford classification from baseline
Time frame: 6, 12, 24 months after index procedure
Secondary Endpoint Efficacy: Change of resting Ankle Brachial Index (ABI) from baseline
Time frame: 6, 12, 24 months after index procedure
Secondary Endpoint Efficacy: Change in Walking Impairment Questionnaire from baseline
Time frame: 6, 12, 24 months after index procedure
Secondary Endpoint Efficacy: Change in quality of life from baseline, as measured by EQ-5D
Time frame: 6, 12, 24 months after index procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- 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.
Martin Banyai, MD, PhD principal investigator
Cantonal Hospital, Lucerne
Prof. Eric Ducasse, MD, PhD principal investigator
University Hospital, Bordeaux
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Artery Occlusion and Femoral Arterial Stenosis, run by C. R. Bard at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. 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 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Belgium, Austria, France, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall Medical Safety (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2019.