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

NCT06835660 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2025-02-19

No results posted yet for this study

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.

Conditions

  • Femoropopliteal Lesion

Interventions

DEVICE

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.

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%.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Raphaël COSCAS, MD, PhD · Department of Vascular Surgery, Ambroise Paré Hospital - AP-HP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2028-11-30
Completion
2028-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06835660 on ClinicalTrials.gov