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

NCT ID: NCT06835660

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 402 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2028-12-31

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.

Conditions

Femoropopliteal Lesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study group (DCB)

Drug coated balloon(s) will be used for femoropopliteal lesions.

Patients assigned to the DCB group (study group) will receive DCB inflation(s) at the level of the lesions according the DCB instructions for use.

Group Type: ACTIVE_COMPARATOR

procedure of DCB implantation

Intervention Type: DEVICE

Patients assigned to the DCB group (study group) will receive DCB inflation(s) at the level of the lesions according the DCB instructions for use (120 seconds inflation minimum). One or several DCBs will be inflated at the level of the lesions depending on lesions' lengths. The DCB diameter(s) will be the one(s) of the index diameter of the artery. Overlaps between zones that will receive DCB inflations will be of 10 mm to avoid any geographic miss.

Comparator group (SEBMS)

Uncovered self-expandable polymer coated paclitaxel eluting stent(s) will be used for femoropopliteal lesions.

Patients assigned to the SEDES group (control group) will receive implantation ELUVIA stents at the level of the lesion(s) according to the SEDES instructions for use.

Group Type: ACTIVE_COMPARATOR

procedure of SEDES implantation

Intervention Type: DEVICE

SEDES implantation wille be performed according to the SEDES instructions for use. Stent(s) oversizing will be of 1 mm maximum. Overlaps between stents will be of 10 mm.

Completion angiogram will assess the technical success of the procedure (see endpoints definitions). The physician may then decide to add a bailout SEBMS because of flow limiting dissection and/or a new stenosis >30%.

Interventions

procedure of DCB implantation

Patients assigned to the DCB group (study group) will receive DCB inflation(s) at the level of the lesions according the DCB instructions for use (120 seconds inflation minimum). One or several DCBs will be inflated at the level of the lesions depending on lesions' lengths. The DCB diameter(s) will be the one(s) of the index diameter of the artery. Overlaps between zones that will receive DCB inflations will be of 10 mm to avoid any geographic miss.

Intervention Type: DEVICE

procedure of SEDES implantation

SEDES implantation wille be performed according to the SEDES instructions for use. Stent(s) oversizing will be of 1 mm maximum. Overlaps between stents will be of 10 mm.

Completion angiogram will assess the technical success of the procedure (see endpoints definitions). The physician may then decide to add a bailout SEBMS because of flow limiting dissection and/or a new stenosis >30%.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raphaël COSCAS, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Vascular Surgery, Ambroise Paré Hospital - AP-HP

Locations

Department of Vascular Surgery, Ambroise Paré Hospital - AP-HP

Boulogne-Billancourt, , France

Countries

France

Central Contacts

Raphaël COSCAS, MD, PhD

Role: CONTACT

raphael.coscas@aphp.fr

+ 33 1 49 09 55 85

Other Identifiers

24RCS-REBOOST

Identifier Type: -

Identifier Source: org_study_id