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

University of Leipzig

Status: Completed

Conditions: Peripheral Artery Disease

Treatments: Device: Ranger Drug Eluting Balloon; Device: In Pact Drug Eluting Balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT02701543

CIP_14/001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 414 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject age ≥ 18
2. 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.
3. Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion.
4. Target lesion length is ≤ 30cm
5. Target lesion is at least 1cm below the origin of the profunda femoris and does not exceed the medial femoral epicondyle.
6. 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.
7. Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation.
8. Patency of at least one (1) infrapopliteal artery to the ankle (< 50% diameter stenosis) in continuity with the native femoropopliteal artery.
9. A guidewire has successfully traversed the target treatment segment.

Exclusion criteria

1. Failure to successfully cross the target lesion
2. Angiographic evidence of severe calcification
3. Presence of fresh thrombus in the lesion.
4. Presence of aneurysm in the target vessel/s
5. Presence of a stent in the target lesion
6. Prior vascular surgery of the target lesion.
7. Stroke or heart attack within 3 months prior to enrollment
8. Any surgical procedure or intervention performed within 30 days prior to or post index procedure
9. Superficial femoropopliteal Artery or Proximal popliteal artery disease in the opposite leg that requires treatment at the index procedure
10. Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices
11. Enrolled in another investigational drug, device or biologic study
12. Life expectancy of less than one year
13. 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
14. Rutherford classification of 0, 1, 5 or 6.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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414 participants in 2 patient groups

Ranger Drug Eluting Balloon

Active Comparator group

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

Treatment:

Device: Ranger Drug Eluting Balloon

In Pact Drug Eluting Balloon

Active Comparator group

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.

Treatment:

Device: In Pact Drug Eluting Balloon