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

February 17, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
402

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Boulogne-Billancourt, France, 92100
        • Department of Vascular Surgery, Ambroise Paré Hospital - AP-HP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
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.
Active Comparator: 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.
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%.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
at 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intraoperative technical success
Time Frame: 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.
through study completion, an average of 24 months
Assisted primary patency
Time Frame: 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.
at 1, 6, 12, 18 and 24 months
Secondary patency
Time Frame: 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.
at 1, 6, 12, 18 and 24 months
Target vessel revascularization
Time Frame: at 1, 6, 12, 18 and 24 months
Target vessel revascularization, defined by any secondary intervention on the ipsilateral femoropopliteal artery above the knee.
at 1, 6, 12, 18 and 24 months
Clinically-driven target vessel revascularization
Time Frame: at 1, 6, 12, 18 and 24 months
Clinically-driven target vessel revascularization
at 1, 6, 12, 18 and 24 months
Target lesion revascularization (TLR)
Time Frame: at 1, 6, 12, 18 and 24 months
Target lesion revascularization (TLR) defined by any secondary intervention on the index lesion.
at 1, 6, 12, 18 and 24 months
Clinically-driven TLR
Time Frame: at 1, 6, 12, 18 and 24 months
Clinically-driven TLR
at 1, 6, 12, 18 and 24 months
Target extremity revascularization
Time Frame: at 1, 6, 12, 18 and 24 months
Target extremity revascularization defined by any revascularization on vascular tree of the ipsilateral limb.
at 1, 6, 12, 18 and 24 months
Binary restenosis
Time Frame: at 1, 6, 12, 18 and 24 months
Binary restenosis, defined as >70% or peak systolic velocity >2.4 m/sec at duplex examination
at 1, 6, 12, 18 and 24 months
Rutherford category
Time Frame: at 1, 6, 12, 18 and 24 months
Rutherford category by Rutherford classification
at 1, 6, 12, 18 and 24 months
ABI value
Time Frame: at baseline, 1, 6, 12, 18 and 24 months
ABI value: ankle-brachial index evaluated by clinical examination
at baseline, 1, 6, 12, 18 and 24 months
Absolute claudication distance improvement
Time Frame: at 1, 6, 12, 18 and 24 months
Absolute claudication distance improvement: evaluated by clinical interview and examination
at 1, 6, 12, 18 and 24 months
Quality of life assessement
Time Frame: at 1, 6, 12, 18 and 24 months
Quality of life assessed by the Walking Impairment Questionnaire (WIQ)
at 1, 6, 12, 18 and 24 months
Cost
Time Frame: at 1, 6, 12, 18 and 24 months
Cost at 1, 6, 12, 18 and 24 months
at 1, 6, 12, 18 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raphaël COSCAS, MD, PhD, Department of Vascular Surgery, Ambroise Paré Hospital - AP-HP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24RCS-REBOOST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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