Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease

Study Overview
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Brief Summary
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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
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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).

Official Title
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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)

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: Ranger Drug Eluting Balloon
* Device: In Pact Drug Eluting Balloon


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ranger Drug Eluting Balloon<br>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 | Device: Ranger Drug Eluting Balloon<br>* 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<br>|
| Active Comparator: In Pact Drug Eluting Balloon<br>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. | Device: In Pact Drug Eluting Balloon<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 
| 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Revascularization (TLR) rate | Target Lesion Revascularization rate at 6, 12, 24, 36, 48 and 60 months | 6,12,24 months | 
| Walking capacity | Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 6, 12 and 24 months versus baseline. | 6,12,24 months | 
| 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 | 6,12,24 months | 
| 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 | 6,12,24 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 | 60 months |