Back to resultsCompare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease
Primary Purpose
Peripheral Artery Disease
Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Ranger Drug Eluting Balloon
In Pact Drug Eluting Balloon
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Subject age ≥ 18
- Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing Rutherford category 2-4.
- Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion.
- Target lesion length is ≤ 30cm
- Target lesion is at least 1cm below the origin of the profunda femoris and does not exceed the medial femoral epicondyle.
- Multiple lesions with max. 3cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion. Total lesion length should not exceed 30 cm.
- Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation.
- Patency of at least one (1) infrapopliteal artery to the ankle (< 50% diameter stenosis) in continuity with the native femoropopliteal artery.
- A guidewire has successfully traversed the target treatment segment.
Exclusion Criteria:
- Failure to successfully cross the target lesion
- Angiographic evidence of severe calcification
- Presence of fresh thrombus in the lesion.
- Presence of aneurysm in the target vessel/s
- Presence of a stent in the target lesion
- Prior vascular surgery of the target lesion.
- Stroke or heart attack within 3 months prior to enrollment
- Any surgical procedure or intervention performed within 30 days prior to or post index procedure
- Superficial femoropopliteal Artery or Proximal popliteal artery disease in the opposite leg that requires treatment at the index procedure
- Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices
- Enrolled in another investigational drug, device or biologic study
- Life expectancy of less than one year
- Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
- Rutherford classification of 0, 1, 5 or 6.
Sites / Locations
- University Clinic Leipzig
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ranger Drug Eluting Balloon
In Pact Drug Eluting Balloon
Arm Description
Intervention with Over the Wire (OTW) Percutaneous transluminal angioplasty (PTA )balloon catheter with a semi-compliant balloon coated with a formulation of 2μg/mm2 paclitaxel and acetyl tri-n-butyl citrate (ATBC) as carrier substance
Intervention with Over the Wire (OTW) peripheral balloon catheter. The balloon surface is coated with a formulation of 3μg/mm2 paclitaxel and urea as carrier substance.
Outcomes
Primary Outcome Measures
Patency rate
Efficacy: patency rate after one year defined as absence of clinically driven Target Lesion Revascularization (due to symptoms and drop of ABI of ≥ 20% or > 0.15 when compared to post-procedure ) or restenosis with Peak Velocity Ratio > 2.4 evaluated by Duplex Ultrasound
Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization
Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization
Secondary Outcome Measures
Target Lesion Revascularization (TLR) rate
Target Lesion Revascularization rate at 6, 12, 24, 36, 48 and 60 months
Walking capacity
Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 6, 12 and 24 months versus baseline.
binary restenosis
Duplex-defined binary restenosis (Peak systolic velocity ratio >2.4) of the target lesion post-procedure and at 6, 12 and 24 months or at any time of re-intervention
improvement shift in Rutherford classification
Sustained clinical improvement: an improvement shift in the Rutherford classification of one class in amputation and Target Vessel Revascularization free surviving patients at 12 months
secondary Safety
Composite of freedom from device and procedure-related death through 60 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02701543
Brief Title
Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease
Official Title
Prospective, Randomized, Multi-Center Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease With the Ranger Paclitaxel Coated PTA Balloon Catheter (Study Arm) Versus the IN.PACT Drug Eluting Balloon (Control Arm)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2015 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare two different Paclitaxel coated balloons in the treatment of high grade stenotic or occluded lesions in Superficial femoropopliteal artery (SFA )and/or Proximal Popliteal Artery in Peripheral Artery Disease (PAD) patients with Rutherford class 2-4.
Detailed Description
This study is a prospective, multi-center 1:1 randomized trial. Patients will be stratified according to lesion length (≤ 10 cm/ > 10 cm and < 20 cm / > 20 cm and ≤ 30 cm). Each strata will include approximately 138 patients.
The trial is to investigate the safety and efficacy of the Ranger™ Drug Coated Balloon in comparison to the IN.PACT™ Drug Coated Balloon in patients with symptomatic femoropopliteal artery disease.
All enrolled subjects will be followed through to 24 months to assess the incidence of restenosis by ultrasound and major adverse events (MAE). Follow-up visits occur at 1, 6, 12 and 24-month intervals per local standard of care. Telephone follow-up visits will occur at 36, 48 and 60 month.
Up to 414 patients will be enrolled at approximately 10-18 sites in Germany for comparison between the following two groups:
Treatment with the Ranger™ Paclitaxel Coated Balloon Catheter (Boston Scientific Corporation, Natick, MA, USA) vs. the IN.PACT™ Drug Eluting Balloon (Medtronic Inc., Minneapolis, MI, USA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
414 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ranger Drug Eluting Balloon
Arm Type
Active Comparator
Arm Description
Intervention with Over the Wire (OTW) Percutaneous transluminal angioplasty (PTA )balloon catheter with a semi-compliant balloon coated with a formulation of 2μg/mm2 paclitaxel and acetyl tri-n-butyl citrate (ATBC) as carrier substance
Arm Title
In Pact Drug Eluting Balloon
Arm Type
Active Comparator
Arm Description
Intervention with Over the Wire (OTW) peripheral balloon catheter. The balloon surface is coated with a formulation of 3μg/mm2 paclitaxel and urea as carrier substance.
Intervention Type
Device
Intervention Name(s)
Ranger Drug Eluting Balloon
Intervention Description
Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries
Intervention Type
Device
Intervention Name(s)
In Pact Drug Eluting Balloon
Intervention Description
Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries
Primary Outcome Measure Information:
Title
Patency rate
Description
Efficacy: patency rate after one year defined as absence of clinically driven Target Lesion Revascularization (due to symptoms and drop of ABI of ≥ 20% or > 0.15 when compared to post-procedure ) or restenosis with Peak Velocity Ratio > 2.4 evaluated by Duplex Ultrasound
Time Frame
1 year
Title
Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization
Description
Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Target Lesion Revascularization (TLR) rate
Description
Target Lesion Revascularization rate at 6, 12, 24, 36, 48 and 60 months
Time Frame
6,12,24 months
Title
Walking capacity
Description
Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 6, 12 and 24 months versus baseline.
Time Frame
6,12,24 months
Title
binary restenosis
Description
Duplex-defined binary restenosis (Peak systolic velocity ratio >2.4) of the target lesion post-procedure and at 6, 12 and 24 months or at any time of re-intervention
Time Frame
6,12,24 months
Title
improvement shift in Rutherford classification
Description
Sustained clinical improvement: an improvement shift in the Rutherford classification of one class in amputation and Target Vessel Revascularization free surviving patients at 12 months
Time Frame
6,12,24 months
Title
secondary Safety
Description
Composite of freedom from device and procedure-related death through 60 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject age ≥ 18
Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing Rutherford category 2-4.
Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion.
Target lesion length is ≤ 30cm
Target lesion is at least 1cm below the origin of the profunda femoris and does not exceed the medial femoral epicondyle.
Multiple lesions with max. 3cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion. Total lesion length should not exceed 30 cm.
Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation.
Patency of at least one (1) infrapopliteal artery to the ankle (< 50% diameter stenosis) in continuity with the native femoropopliteal artery.
A guidewire has successfully traversed the target treatment segment.
Exclusion Criteria:
Failure to successfully cross the target lesion
Angiographic evidence of severe calcification
Presence of fresh thrombus in the lesion.
Presence of aneurysm in the target vessel/s
Presence of a stent in the target lesion
Prior vascular surgery of the target lesion.
Stroke or heart attack within 3 months prior to enrollment
Any surgical procedure or intervention performed within 30 days prior to or post index procedure
Superficial femoropopliteal Artery or Proximal popliteal artery disease in the opposite leg that requires treatment at the index procedure
Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices
Enrolled in another investigational drug, device or biologic study
Life expectancy of less than one year
Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
Rutherford classification of 0, 1, 5 or 6.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dierk Scheinert, Prof.Dr.
Organizational Affiliation
University Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic Leipzig
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04103
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36265942
Citation
Steiner S, Schmidt A, Zeller T, Tepe G, Thieme M, Maiwald L, Schroder H, Euringer W, Popescu C, Brechtel K, Brucks S, Blessing E, Schuster J, Langhoff R, Schellong S, Weiss N, Beschorner U, Wittig T, Scheinert D. Low-Dose vs High-Dose Paclitaxel-Coated Balloons for Femoropopliteal Lesions: 2-Year Results From the COMPARE Trial. JACC Cardiovasc Interv. 2022 Oct 24;15(20):2093-2102. doi: 10.1016/j.jcin.2022.08.004. Epub 2022 Sep 28.
Results Reference
derived
PubMed Identifier
31989155
Citation
Steiner S, Schmidt A, Zeller T, Tepe G, Thieme M, Maiwald L, Schroder H, Euringer W, Ulrich M, Brechtel K, Brucks S, Blessing E, Schuster J, Langhoff R, Schellong S, Weiss N, Scheinert D. COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions. Eur Heart J. 2020 Jul 14;41(27):2541-2552. doi: 10.1093/eurheartj/ehaa049.
Results Reference
derived
Learn more about this trial
Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease
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