NCT06835660: REBOOST

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

Not yet recruiting NA Last updated 17 February 2025

What this trial tests

NA trial testing procedure of DCB implantation in Femoropopliteal Lesion in 402 participants. Not yet recruiting.

Timeline

1 May 2025

Primary endpoint
1 November 2028

1 December 2028

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	402
Start date	1 May 2025
Primary completion	1 November 2028
Estimated completion	1 December 2028
Sites	1 location across France

Drugs / interventions tested

• procedure of DCB implantation
• procedure of SEDES implantation

Conditions studied

• Femoropopliteal Lesion — all drugs for Femoropopliteal Lesion →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Femoropopliteal Lesion. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Loss of primary patency
  Time frame: 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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.