DRug-Eluting BallOOn Versus Primary Polymer-coated Paclitaxel Eluting STenting for Femoro-popliteal Lesions

Not Applicable

Not yet recruiting

• Conditions: Femoropopliteal Lesion

• Registration Number: NCT06835660
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Main objective of the study: To demonstrate that a primary DCB strategy is non-inferior in terms of primary patency to a primary SEDES strategy for above-the-knee femoro-popliteal lesions at 12 months.

Primary endpoint: Freedom from loss of primary patency at 12 months: loss of primary patency will be defined as the need for target vessel revascularization and/or binary restenosis (defined as \>70% in diameter or peak systolic velocity \>2.4 m/sec at duplex examination).

Secondary objectives:

To demonstrate that a primary DCB strategy is non-inferior to a primary SEDES strategy in terms of:

* Intra-operative technical success.

* Safety at 1, 6, 12, 18 and 24 months.

* Primary patency at 1, 6, 12, 18 and 24 months.

* Assisted primary patency at 1, 6, 12, 18 and 24 months.

* Secondary patency at 1, 6, 12, 18 and 24 months.

* All target vessel revascularization at 1, 6, 12, 18 and 24 months.

* Clinically-driven target vessel revascularization at 1, 6, 12, 18 and 24 months.

* All TLR at 1, 6, 12, 18 and 24 months.

* Clinically-driven TLR at 1, 6, 12, 18 and 24 months.

* All target extremity revascularization at 1, 6, 12, 18 and 24 months.

* Number of secondary interventions at 1, 6, 12, 18 and 24 months.

* Binary restenosis at 1, 6, 12, 18 and 24 months.

* Mean Rutherford category at 1, 6, 12, 18 and 24 months.

* Mean ABI value at 1, 6, 12, 18 and 24 months.

* Absolute claudication distance improvement at 1, 6, 12, 18 and 24 months.

* Quality of life at 1, 6, 12, 18 and 24 months.

* Cost at 1, 6, 12, 18 and 24 months.

Detailed Description

Femoropopliteal lesions (FPL) are the most common localization of lower limb peripheral arterial disease (LLPAD). Previous prospective randomized studies conducted in the 2000s demonstrated the superiority of self-expandable bare metal stent (SEBMS) placement over plain balloon angioplasty (PBA) in FPL at 12 months, 24 months and beyond. Recent studies show a significant benefit of self expandable polymer-coated paclitaxel eluting stents (SEDES) over SEBMS and led to consider SEDES implantation as the treatment of choice for FPL, especially in France with ≈45 000 self expandable stents implantations per year at this level. More recently, prospective randomized trials demonstrated that drug-coated balloon (DCB) use was superior to PBA in FPL at 12 months, 24 months and beyond. Primary patency at 12 months of both SEDES and DCB appeared in the same ranges.

SEDES and DCB are therefore now recognized as two valuable options for FPL and they are both reimbursed for the treatment of such lesions. However, the choice between the two treatment strategies remains unclear. On one hand, primary SEDES allows a secure approach that limits the risk of post-angioplasty dissection and thrombosis, but a permanent metallic scaffold remains inside the treated artery, with a late risk of stent fracture and challenging in-stent restenosis. On the other hand, DCB may be at risk of early arterial recoil but allows leaving nothing behind in the arterial bed. Early recoil mandates self expandable stents implantation after DCB with an increased procedural cost in approximately 10% of patients. Since no rigorous independent trial directly compared these two strategies, this study will prospectively compare SEDES and DCB for above-the-knee FPL.

This study is a non-inferiority, prospective, comparative trial. Patients will be screened using clinical and duplex scan examinations. Patients matching inclusion criteria and without exclusion criteria will give written informed consent before the endovascular revascularization procedure.

Technically, following puncture of the femoral artery, an angiogram will be performed. The lesion(s) will be identified and crossed by a guidewire. Vessel preparation (predilatation) will be performed using PBA at the level of the lesion up to the index diameter of the artery (60 seconds minimum). Another angiogram will determine technical success or failure of the predilatation. Predilatation success is defined as the absence of flow limiting dissection and/or residual stenosis \>30%. Patients with predilatation failure will receive an adequate treatment (generally a provisional stenting) at the physician's discretion. These patients with predilatation failure will not be randomized and will not be further followed in the study. Patients with predilatation success will then be randomized intraoperatively to a DCB or a SEDES strategy using a dedicated web server with stratification on Center, Rutherford category (2-3/4) and lesion length (short vs. long lesion, as described above). Participants will be distributed between groups at a ratio of (1:1).

After the procedure, patients will be prescribed clopidogrel for 90 days and aspirin for lifelong.

Patients will be assessed at 1, 6, 12, 18 and 24 months follow-up with clinical and duplex-scan examination. An independent core laboratory will examine duplex-scan results.

15 national sites/recruitment centers will be involved in the study targetting 402 patients.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-17
• Last Update Submitted: 2025-02-17
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Study Start: 2025-05
• Primary Completion: 2028-11
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 402

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.
• Rutherford category 2-4.
• Femoro-popliteal stenosis/occlusion
• Target lesion is below the origin of the profunda femoris and does not exceed the medial femoral epicondyle.
• Patent inflow artery (<30% diameter stenosis).
• Patency of at least one infrapopliteal artery to the ankle (<30% diameter stenosis) in continuity with the native femoropopliteal artery.

Exclusion Criteria

• Inability to obtain informed consent.
• Life expectancy <24 months.
• Pregnancy or breastfeeding during study period.
• Known clotting disorders.
• Contraindication to antiplatelet therapy or anticoagulants.
• Known hypersensitivity to nitinol or paclitaxel.
• Enrollment into another study.
• Significant iliac or common femoral stenosis (<30% diameter) requiring intervention during the index procedure.
• In-stent restenosis
• Total occlusion non-crossable by a guidewire.
• Acute thrombosis of target vessel
• Prior ipsilateral femoro-popliteal bypass.
• Implantation of a drug-eluting stent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Loss of primary patency	at 12 months	Freedom from loss of primary patency at 12 months: loss of primary patency will be defined as the need for target vessel revascularization and/or binary restenosis.; defined as \>70% in diameter or peak systolic velocity \>2.4 m/sec at duplex examination

Secondary Outcome Measures

Name	Time	Method
Intraoperative technical success	through study completion, an average of 24 months	Intraoperative technical success, defined as the absence of flow limiting dissection or residual stenosis \>30% at the final completion angiogram.
Assisted primary patency	at 1, 6, 12, 18 and 24 months	Assisted primary patency is defined as vessel patency even when maintained by repeated percutaneous intervention, but prior to complete vessel occlusion.
Secondary patency	at 1, 6, 12, 18 and 24 months	Secondary patency is defined as vessel patency even when maintained by repeated percutaneous intervention, prior or after complete vessel occlusion.
Clinically-driven target vessel revascularization	at 1, 6, 12, 18 and 24 months	Clinically-driven target vessel revascularization
Target lesion revascularization (TLR)	at 1, 6, 12, 18 and 24 months	Target lesion revascularization (TLR) defined by any secondary intervention on the index lesion.
Target vessel revascularization	at 1, 6, 12, 18 and 24 months	Target vessel revascularization, defined by any secondary intervention on the ipsilateral femoropopliteal artery above the knee.
Clinically-driven TLR	at 1, 6, 12, 18 and 24 months	Clinically-driven TLR
Target extremity revascularization	at 1, 6, 12, 18 and 24 months	Target extremity revascularization defined by any revascularization on vascular tree of the ipsilateral limb.
Binary restenosis	at 1, 6, 12, 18 and 24 months	Binary restenosis, defined as \>70% or peak systolic velocity \>2.4 m/sec at duplex examination
Rutherford category	at 1, 6, 12, 18 and 24 months	Rutherford category by Rutherford classification
ABI value	at baseline, 1, 6, 12, 18 and 24 months	ABI value: ankle-brachial index evaluated by clinical examination
Absolute claudication distance improvement	at 1, 6, 12, 18 and 24 months	Absolute claudication distance improvement: evaluated by clinical interview and examination
Quality of life assessement	at 1, 6, 12, 18 and 24 months	Quality of life assessed by the Walking Impairment Questionnaire (WIQ)
Cost	at 1, 6, 12, 18 and 24 months	Cost at 1, 6, 12, 18 and 24 months

Trial Locations

Locations (1)

Department of Vascular Surgery, Ambroise Paré Hospital - AP-HP; 🇫🇷 Boulogne-Billancourt, France