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

NCT02701543 | Completed DMC

• 1 other identifier: CIP_14/001
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Target Lesion Revascularization (TLR) rate

  6,12,24 months

• Walking capacity

  6,12,24 months

• binary restenosis

  6,12,24 months

• improvement shift in Rutherford classification

  6,12,24 months

• secondary Safety

  60 months

Study Arms (2)

Ranger Drug Eluting Balloon

ACTIVE COMPARATOR

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

In Pact Drug Eluting Balloon

ACTIVE COMPARATOR

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

Interventions

Ranger Drug Eluting Balloon DEVICE

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

Ranger Drug Eluting Balloon

In Pact Drug Eluting Balloon DEVICE

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

In Pact Drug Eluting Balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

University Clinic Leipzig

Leipzig, Saxony, 04103, Germany

Location

Related Publications (2)

• 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.

  PMID: 36265942 DERIVED

• 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.

  PMID: 31989155 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Dierk Scheinert, Prof.Dr.

  University Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: March 8, 2016
• Study Start: October 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

DE (1)