BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery

NCT03776799 | Active Not Recruiting DMC

• 1 other identifier: CIP_18/001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, multi-center 1:1 randomized trial to compare efficacy and safety of a stent-avoiding (using drug coated balloons) versus a stent-preferred (using drug eluting or interwoven stents) approach for treatment of complex femoropopliteal lesions TASC II (TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease) Type B-D (stenosis \>10cm, occlusions \>5cm).

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Primary patency - Absence of clinically-driven target lesion revascularization (CD-TLR) and/or restenosis defined as a peak systolic velocity ratio (PSVR) > 2.4 assessed by ultrasound

  1 Year

Secondary Outcomes (4)

• Walking capacity - Walking capacity assessed by Walking impairment questionnaire score at 6, 12 and 24

  2 Year

• Ankle-brachial index - Clinical improvment assessed by Ankle-brachial index at 6, 12 and 24 month

  2 Year

• Rutherford category - Clinical improvment assessed by Rutherford category at 6, 12 and 24 month

  2 Year

• Freedom from device and procedure-related death, all-cause death, target limb major amputation and clinically-driven target lesion revascularization

  5 Years

Study Arms (2)

Stent-avoiding approach

OTHER

using clinically proven drug coated balloons

Device: Stent-avoiding

Stent-based approach

OTHER

using drug eluting nitinol stents. Interwoven nitinol stents in heavily calcified lesions at the operator's discretion.

Device: Stent-based

Interventions

Stent-avoiding 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

Stent-avoiding approach

Stent-based DEVICE

Stenting, in which a stent is advanced and implanted in the obstructed artery, has become the standard endovascular treatment for peripheral arteries

Stent-based approach

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.
• Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion.
• Rutherford Becker Classification 2-4
• Both treatment options seem feasible at the operator's discretion
• Femoropopliteal lesions classified as TASC II Type B-D with a maximum lesion length ≤ 30cm not involving the infrageniculate popliteal artery are eligible.
• 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. The inflow artery(ies) cannot be treated using a drug eluting stent or drug coated balloon
• 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 that makes a stent-avoiding approach not feasible at the operator's discretion.
• Femoropopliteal lesions classified as TASC II Typ A (single stenosis \>=10cm and single occlusion \>=5cm)
• 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 planned surgical procedure or intervention performed within 30 days prior to or post index procedure
• SFA or PPA disease in the opposite leg that requires treatment at the index procedure
• Enrolled in another investigational drug, device or biologic study that interferes with the 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.
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

University Clinic Leipzig

Leipzig, Saxony, 04103, Germany

Location

Related Publications (1)

• Wittig T, Schmidt A, Fuss T, Thieme M, Maiwald L, Dusing S, Konert M, Fischer A, Scheinert D, Steiner S. Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv. 2024 May 13;17(9):1134-1144. doi: 10.1016/j.jcin.2024.03.015.

  PMID: 38749594 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 Clinic 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: Clinic director

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 17, 2018
• Study Start: January 1, 2019
• Primary Completion: August 24, 2022
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

DE (1)