Peripheral Arterial DiseaseNCT03547986
BIO REsponse Adapted Combination Therapy Pilot Study
A study testing Duplex Ultrasound (DUS) and IVUS with Intraarterial pressure measurement (IAP) if needed in people with Peripheral Arterial Disease, run by Biotronik AG at 15 sites in 6 countries.
Trial summary
Both drug-coated balloon and stents have been used for a number of years to treat subjects with Peripheral Artery Disease (PAD) and are recognized as very good treatment methods. 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?
- Duplex Ultrasound (DUS) and IVUS with Intraarterial pressure measurement (IAP) if needed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 9 Nov 2018to Mar 2024
- Phase
- Interventional
- 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
Who may be able to join
- Subject has provided written informed consent before any study specific test or procedure and is willing and able to comply with the required follow-up visits and procedures
- Subject has a chronic, symptomatic lower limb ischemia defined as Rutherford categories 2 to 4
- Angiographic criteria:
- Single lesion or consecutive single lesions with a healthy segment(s) of ≤ 2cm in-between
- De novo, restenotic or (re)occluded lesion(s) post Percutaneous Transluminal Angioplasty in the native superficial femoral artery (SFA) and or the proximal popliteal artery (PPA)
- Lesion(s) must be located at least 1 cm distal to the profunda femoris artery and at least 3 cm above the knee joint (radiographic joint space)
Show all 10Show fewer
- Degree of stenosis ≥70% by visual angiographic assessment
- Vessel diameter ≥ 4 and ≤ 7 mm
- Patent inflow artery, free from significant lesion (>50%) as confirmed by angiography. Treatment of the target lesion is acceptable after successful treatment of inflow iliac and/or common femoral artery lesion. The inflow lesion cannot be treated with a DCB or a Drug Eluting Stent
- Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of the three vessels patent (<50% stenosis) to the ankle or foot with no planned intervention
Who cannot join
- Previously stented target lesion
- Target lesion/ previously treated with drug-coated balloon <12 months prior to enrollment.
- Use of atherectomy, laser or other debulking devices in the target SFA/PPA vessel during the index procedure.
- Failure to cross the target lesion with the guide wire
- Presence of a complication following pre-dilation of target lesion, which in the opinion of the investigator would not allow the procedure to be performed in accordance with the REACT approach
- Presence of aneurysm in the target vessel.
Show all 17Show fewer
- Prior on planned major amputation (above the ankle) in the target limb
- Acute ischemia and/or acute thrombosis of the target SFA/PPA vessel prior to enrollment.
- Perforation of the target vessel as evidenced by extravasation of contrast media prior to enrollment
- Known hypersensitivity or contraindication to contrast media that, in the opinion of the investigator, cannot be adequately pre-medicated
- Known hypersensitivity/allergy to Paclitaxel or other components of the investigational devices and comparator (e.g., nitinol, amorphous silicon carbide, polymer)
- Known hypersensitivity or contraindication to antiplatelet, anticoagulant, thrombolytic medications that would be administered during the study
- Subject with uncorrected bleeding disorders
- Subject with renal failure
- Life expectancy less than 12 months due to other comorbidities, that in the investigators opinion, could limit subject ability to comply with the study required follow-up visits/procedure and threaten the study scientific integrity
- Pregnant, breast feeding, or plan to become pregnant in the next 12 months.
- Current participation in another investigational drug or device clinical study that has not completed the primary endpoint at the time of enrollment or that upon investigator judgment could clinically interferes with the current study endpoints
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
Germany6 sites
Karolinen-Hospital, Klinikum Arnsberg
Arnsberg
Universitäts-Herzzentrum Freiburg • Bad Krozingen
Bad Krozingen, 79189
SRH Klinikum Karlsbad-Langensteinbach
Biederbach Baden-Wurttemberg
Universitätsklinikum Leipzig
Leipzig
Universitätsklinikum
Tübingen
GRN Hospital
Weinheim
Belgium3 sites
OLV Ziekenhuis
Aalst
A.Z. Sint-Blasius
Dendermonde
AZ Groeninge
Kortrijk
Austria2 sites
Medical University Graz
Graz
Medizinische Universität Wien
Vienna
About this study
Official title: Evaluation of Adjunctive Procedural Assessments to Diagnose Post Drug-coated Balloon Flow-limiting Dissection and Residual Stenosis When Angiography is Inconclusive
Both drug-coated balloon and stents have been used for a number of years to treat subjects with Peripheral Artery Disease (PAD) and are recognized as very good treatment methods. However, due to a higher risk of blood clot formation, requiring a longer anticoagulant treatment, and the challenge of treating re growth of tissue extending through the metal mesh of the stent, the physicians try to reserve stent placement to situation where it's really needed, in case of flow-limiting vessel dissection or acute re-narrowing.
The purpose of this study is to evaluate the utility of several procedural diagnostic techniques in helping the physicians to better decide whether a stent is needed or not.
The study will also estimate the safety and efficacy of Passeo-18 Lux drug-coated balloon associated to Pulsar 18 bare metal stent when and where needed to treat PAD
Read the detailed description
The REACT treatment concept aims at minimizing the metal burden, combining Passeo-18 Lux Drug-Coated Balloon (DCB) with Pulsar-18 thin struts bare metal stent, as low as reasonably achievable (ALARA), while benefiting from the antirestenotic properties of Paclitaxel. However, in order to optimally apply this selective stenting approach, it is needed to clearly identify when a stent is indicated. Angiographic images, even with additional projections, are sometimes insufficient to clearly determine if a dissection is flow-limiting and the subsequent stent requirement. There is currently no definition nor validated method to define flow-limiting dissection in the peripheral arteries. Even though it has been widely used, the classification developed by the National Heart, Lung, and Blood Institute to grade coronary artery dissection as A to F19, based on angiographic appearance cannot be extrapolated to peripheral arteries.
Therefore, the purpose of the study is to evaluate the incremental value of several adjunctive procedural assessments to standard angiography to identify flow-limiting dissection and residual stenosis, and better inform the operator on the stent requirement. In addition, the study will evaluate the safety and efficacy of the REACT algorithm.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Duplex Ultrasound (DUS), IVUS with Intraarterial pressure measurement (IAP) if needed
- Keywords
- flow-limiting dissection, residual stenosis
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duplex Ultrasound (DUS)Diagnostic test
Also called Procedural diagnostic with Duplex Ultrasound (DUS)
Occurrence of a flow-limiting dissection or residual stenosis will be assessed by standard angiography and Duplex Ultrasound
IVUS with Intraarterial pressure measurement (IAP) if neededDiagnostic test
Also called Procedural diagnostic with IVUS and Intraarterial pressure measurement (IAP)
Occurrence of a flow-limiting dissection or residual stenosis will be assessed by standard angiography and Intra-vascular ultrasound associated to Intraarterial pressure measurement if needed
| Study group | Role | What they receive |
|---|---|---|
| Duplex Ultrasound (DUS) | Experimental | Standard angiography and DUS are performed on the same patients (paired data) Receives: Diagnostic Test: Duplex Ultrasound (DUS) |
| IVUS with Intraarterial pressure measurement (IAP) | Experimental | Standard angiography and Intra-Vascular Ultrasound (IVUS) with Intraarterial pressure measurement (IAP) are performed on the same patients (paired data) Receives: Diagnostic Test: IVUS with Intraarterial pressure measurement (IAP) if needed |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy of duplex ultrasound
specificity and sensitivity of duplex ultrasound combined to angiography vs angiography alone
Measured: during index procedure
Secondary outcomes (22)
diagnostic accuracy of intraarterial pressure measurement
specificity and sensitivity of intraarterial pressure measurement combined to angiography vs angiography alone
Measured: during index procedure
diagnostic accuracy of intraarterial pressure measurement with IVUS
specificity and sensitivity of intraarterial pressure measurement with IVUS combined to angiography vs angiography alone
Measured: during index procedure
Target lesion stenting rate
Measured: during index procedure
Number of stents used per target lesion
Measured: during index procedure
Average stent length per target lesion
Measured: during index procedure
Average target lesion length stented (full, spot)
Measured: during index procedure
DCB technical success
Delivery and successful use of Passeo-18 Lux DCB to the target lesion to achieve a residual stenosis no greater than 30% in the absence of flow-limiting dissection
Measured: during index procedure
Stent technical success
delivery and successful use of Pulsar-18 to the target lesion to achieve a residual stenosis no greater than 30%
Measured: during index procedure
Procedural success
technical success and no MAEs before discharge
Measured: during index procedure
Primary Patency
Primary patency is defined as DUS peak systolic velocity ratio (PSVR) ≤2.5 at the target lesion, in the absence of clinically driven Target Lesion Revascularization (cd TLR).
Measured: 1, 6 and 12 months post index procedure
Major Adverse Event (MAE)
Major adverse event (MAE) is defined as device or procedure related death within 30 days post index procedure, major target limb amputation or cd TLR post index procedure
Measured: 1, 6 and 12 months post index procedure
Major Adverse Cardiac Event (MACE)
Major adverse Cardiac event (MACE) is defined as death all causes, myocardial infarction, stroke, death or major amputation
Measured: 1, 6 and 12 months post index procedure
Major Adverse Limb Event (MALE)
Major adverse limb event (MALE) is defined as severe limb ischemia leading to an intervention or major vascular amputation
Measured: 1, 6 and 12 months post index procedure
Clinically driven Target Lesion Revascularization
Clinical Event Committee adjudicated TLR =Any post index procedure surgical or percutaneous intervention to the target lesion plus 5 mm proximal and distal to the stented lesion edge when a stent is used
Measured: 1, 6, 12, 24 and 36 months post index procedure
Major target limb amputation rate
Measured: 1, 6, 12, 24 and 36 months post index procedure
all cause of death rate
Measured: 1, 6, 12, 24 and 36 months post index procedure
Hemodynamic improvement
change in Ankel Brachial Index at 1, 6 and 12 months post index procedure compared to baseline
Measured: 1, 6 and 12 months post index procedure
Rate of primary sustained clinical improvement
Improvement in Rutherford Classification of at least one category for claudicants and by wound-healing and resting pain resolution for critical limb ischemia as compared to pre-procedure without the need for repeat TLR
Measured: 1, 6 and 12 months post index procedure
Rate of secondary sustained clinical improvement
Improvement in Rutherford Classification of at least one category for claudicants and by wound-healing and resting pain resolution for critical limb ischemia as compared to pre-procedure including the need for repeat TLR
Measured: 1, 6 and 12 months post index procedure
Health Related Quality of Life
The Euroquol Group 5 dimension quality of life questionnaire (EQ-5D) is a descriptive system comprising 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The results in a 1-digit number expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes patient's health state.
The EQ Visual Analogue Scale records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement
Measured: baseline, 1, 6 and 12 months post index procedure
Walk Impairment
The Walk Impairment Questionnaire (WIQ) measure measures self-reported walking distance, walking speed, and stair-climbing ability
Measured: baseline, 1, 6 and 12 months post index procedure
Resource utilisation
Costs will be evaluated using specific information on resource use
Measured: during index procedure, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start9 Nov 2018
- Primary completion3 Jan 2022
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The existing and new diagnostic method are performed on the same patients (paired data)
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Koen Deloose, MD, Principal investigator, Sint Blasius Hospital Dendermonde, BelgiumPatrice Bibombe Mwipatayi, MD, Principal investigator, Royal Perth HospitalMichael Lichtenberg, MD, Principal investigator, Clinic Arnsberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547986
- Sponsor's protocol ID
- C1706
- Status last verified
- Aug 2022
- First submitted
- 18 May 2018
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adjunctive Procedural Assessments to Diagnose Post Drug-coated Balloon Flow-limiting Dissection and Residual Stenosis When Angiography is Inconclusive
- ClinicalTrials.gov ID
- NCT03547986
- Acronym / sponsor ID
- C1706
- Conditions
- Peripheral Arterial Disease
- Keywords
- flow-limiting dissection, residual stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- Mar 2024 (estimated)
- First posted
- 6 Jun 2018 (actual)
- 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.
Both drug-coated balloon and stents have been used for a number of years to treat subjects with Peripheral Artery Disease (PAD) and are recognized as very good treatment methods. However, due to a higher risk of blood clot formation, requiring a longer anticoagulant treatment, and the challenge of treating re growth of tissue extending through the metal mesh of the stent, the physicians try to reserve stent placement to situation where it's really needed, in case of flow-limiting vessel dissection or acute re-narrowing.
The purpose of this study is to evaluate the utility of several procedural diagnostic techniques in helping the physicians to better decide whether a stent is needed or not.
The study will also estimate the safety and efficacy of Passeo-18 Lux drug-coated balloon associated to Pulsar 18 bare metal stent when and where needed to treat PAD
Detailed description
The REACT treatment concept aims at minimizing the metal burden, combining Passeo-18 Lux Drug-Coated Balloon (DCB) with Pulsar-18 thin struts bare metal stent, as low as reasonably achievable (ALARA), while benefiting from the antirestenotic properties of Paclitaxel. However, in order to optimally apply this selective stenting approach, it is needed to clearly identify when a stent is indicated. Angiographic images, even with additional projections, are sometimes insufficient to clearly determine if a dissection is flow-limiting and the subsequent stent requirement. There is currently no definition nor validated method to define flow-limiting dissection in the peripheral arteries. Even though it has been widely used, the classification developed by the National Heart, Lung, and Blood Institute to grade coronary artery dissection as A to F19, based on angiographic appearance cannot be extrapolated to peripheral arteries.
Therefore, the purpose of the study is to evaluate the incremental value of several adjunctive procedural assessments to standard angiography to identify flow-limiting dissection and residual stenosis, and better inform the operator on the stent requirement. In addition, the study will evaluate the safety and efficacy of the REACT algorithm.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The existing and new diagnostic method are performed on the same patients (paired data)
| Arm | Type | Receives |
|---|---|---|
| Duplex Ultrasound (DUS) | Experimental | Diagnostic Test: Duplex Ultrasound (DUS)Standard angiography and DUS are performed on the same patients (paired data) |
| IVUS with Intraarterial pressure measurement (IAP) | Experimental | Diagnostic Test: IVUS with Intraarterial pressure measurement (IAP) if neededStandard angiography and Intra-Vascular Ultrasound (IVUS) with Intraarterial pressure measurement (IAP) are performed on the same patients (paired data) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject has provided written informed consent before any study specific test or procedure and is willing and able to comply with the required follow-up visits and procedures
- Subject has a chronic, symptomatic lower limb ischemia defined as Rutherford categories 2 to 4
- Single lesion or consecutive single lesions with a healthy segment(s) of ≤ 2cm in-between
- De novo, restenotic or (re)occluded lesion(s) post Percutaneous Transluminal Angioplasty in the native superficial femoral artery (SFA) and or the proximal popliteal artery (PPA)
- Lesion(s) must be located at least 1 cm distal to the profunda femoris artery and at least 3 cm above the knee joint (radiographic joint space)
Key exclusion criteria (17 listed)
- Previously stented target lesion
- Target lesion/ previously treated with drug-coated balloon <12 months prior to enrollment.
- Use of atherectomy, laser or other debulking devices in the target SFA/PPA vessel during the index procedure.
- Failure to cross the target lesion with the guide wire
- Presence of a complication following pre-dilation of target lesion, which in the opinion of the investigator would not allow the procedure to be performed in accordance with the REACT approach
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 |
|---|---|---|
| Duplex Ultrasound (DUS)Also: Procedural diagnostic with Duplex Ultrasound (DUS)Occurrence of a flow-limiting dissection or residual stenosis will be assessed by standard angiography and Duplex Ultrasound | Diagnostic test | Duplex Ultrasound (DUS) |
| IVUS with Intraarterial pressure measurement (IAP) if neededAlso: Procedural diagnostic with IVUS and Intraarterial pressure measurement (IAP)Occurrence of a flow-limiting dissection or residual stenosis will be assessed by standard angiography and Intra-vascular ultrasound associated to Intraarterial pressure measurement if needed | Diagnostic test | IVUS with Intraarterial pressure measurement (IAP) |
Primary outcome
diagnostic accuracy of duplex ultrasound
Time frame: during index procedure
specificity and sensitivity of duplex ultrasound combined to angiography vs angiography alone
22 secondary outcomes
diagnostic accuracy of intraarterial pressure measurement
Time frame: during index procedure
diagnostic accuracy of intraarterial pressure measurement with IVUS
Time frame: during index procedure
Target lesion stenting rate
Time frame: during index procedure
Number of stents used per target lesion
Time frame: during index procedure
Average stent length per target lesion
Time frame: during index procedure
Average target lesion length stented (full, spot)
Time frame: during index procedure
DCB technical success
Time frame: during index procedure
Stent technical success
Time frame: during index procedure
Procedural success
Time frame: during index procedure
Primary Patency
Time frame: 1, 6 and 12 months post index procedure
Major Adverse Event (MAE)
Time frame: 1, 6 and 12 months post index procedure
Major Adverse Cardiac Event (MACE)
Time frame: 1, 6 and 12 months post index procedure
Major Adverse Limb Event (MALE)
Time frame: 1, 6 and 12 months post index procedure
Clinically driven Target Lesion Revascularization
Time frame: 1, 6, 12, 24 and 36 months post index procedure
Major target limb amputation rate
Time frame: 1, 6, 12, 24 and 36 months post index procedure
all cause of death rate
Time frame: 1, 6, 12, 24 and 36 months post index procedure
Hemodynamic improvement
Time frame: 1, 6 and 12 months post index procedure
Rate of primary sustained clinical improvement
Time frame: 1, 6 and 12 months post index procedure
Rate of secondary sustained clinical improvement
Time frame: 1, 6 and 12 months post index procedure
Health Related Quality of Life
Time frame: baseline, 1, 6 and 12 months post index procedure
Walk Impairment
Time frame: baseline, 1, 6 and 12 months post index procedure
Resource utilisation
Time frame: during index procedure, 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- 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.
Koen Deloose, MD principal investigator
Sint Blasius Hospital Dendermonde, Belgium
Patrice Bibombe Mwipatayi, MD principal investigator
Royal Perth Hospital
Michael Lichtenberg, MD principal investigator
Clinic Arnsberg
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duplex Ultrasound (DUS) and IVUS with Intraarterial pressure measurement (IAP) if needed in people with Peripheral Arterial Disease, run by Biotronik AG at 15 sites in 6 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 10 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, Belgium, Austria, France, Australia and 1 more country. 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?
Results are not available in the source record.
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?
diagnostic accuracy of duplex ultrasound (time frame: during index procedure). 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 29 Aug 2022.