Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions (TOCAF)

December 16, 2025 updated by: University Hospital, Lille
This is a common care study. A study for evaluating the quality of balloon inflation and stent application will be performed in 2D angiography alone in the control group and then by 2D and OCT angiography for the experimental group. The benefit could be an improvement in the results of revascularization of femoropopliteal lesions thanks to OCT which allows a 3D visualization of the arterial lumen.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

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.
166

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
      • Lille, France, 59037
        • Recruiting
        • Insitut Coeur-Poumon, CHU
        • Principal Investigator:
          • Jonathan SOBOCINSKI, MD
        • Contact:
          • Phone Number: 0320445962

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient over 18 years old
  • Femoral-popliteal lesion TASC-C or TASC-D de novo (F1 to P1)
  • Starting lesion on the superficial femoral artery and not extending beyond the intercondylar notch (P2)
  • ≥1 continuous permeable leg axis directly injecting the plantar arch
  • Rutherford 2-5

Exclusion Criteria:

  • Patient under personal protection regime (tutorship, guardianship)
  • Absence of arterial axis in permeable leg
  • Patient presenting a limb acute ischaemia (chart evolving since less than 14 days)
  • Patient without favorable element to consider healing
  • History of stents on the femoropopliteal axis
  • History of femoropopliteal bypass
  • Untreated stenosis ≥30% on the iliac axis and common femoral upstream
  • Popliteal lesion beyond the intercondylar notch (P2)

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.
Sham Comparator: angiography 2D
Control group: an arteriography will be performed on the entire treated segment to assess the quality of the result, the application or not an active balloon will be left to the discretion of the operator. In case of application of the active balloon, a new arteriography before decision or not the use of stenting will be practiced. In case of stenting, an arteriographic final is performed.
Device: femoropopliteal revascularization for TASC C or TASC D lesion
Femoropopliteal revascularization: ATL or ATL/stenting for TASC C/D lesions. Control group: only angiography 2D final control. Experimental group: angiography + OCT control
Experimental: angiography 2D with OCT
Experimental group: an arteriography and OCT acquisition on the entire treated segment to ensure the quality of the result, the application or not of an active ball will be left. In case of application of the active balloon, a new arteriography and OCT acquisition before decision or not the use of stenting will be practiced. In case of stenting, a final arteriography and then OCT acquisition are performed.
Device: femoropopliteal revascularization for TASC C or TASC D lesion
Femoropopliteal revascularization: ATL or ATL/stenting for TASC C/D lesions. Control group: only angiography 2D final control. Experimental group: angiography + OCT control

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
Primary patency rate at 1 year.
Time Frame: at 12 months (+/- 2months)
The permeability rate is defined by the echodoppler criteria: PVS>2.4m/s or appearance of stenosis on the previously treated segment >70%.
at 12 months (+/- 2months)

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
Primary patency rate at 1 year.
Time Frame: at 1month (+/- 10days), 6months (+/- 1month)
at 1month (+/- 10days), 6months (+/- 1month)
Target lesion revascularisation
Time Frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
corresponds to the occurrence of a re-intervention on the treated segment to maintain or restore permeability
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Target vessel revascularisation
Time Frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
corresponds to the occurrence of a re-intervention on the previously treated artery, whatever the level, in order to maintain its permeability.
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
cost-effectiveness analyses
Time Frame: at 12 months (+/- 2months)
Cost-effectiveness analysis between 2 therapeutic strategies: The costs related to each strategy are calculated taking into account the direct and indirect costs.
at 12 months (+/- 2months)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rutherford scale considered ordinal variable
Time Frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Rutherford grade of 2-4 for their target leg. The Rutherford scale is an indicator for the severity of Peripheral Vascular Disease: 0 = no symptoms, 6 = functional foot is no longer salvageable (leading to foot amputation).
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Variation in Ankle Brachial Index between randomization and 1, 6, 12 months on the revascularized limb in the study.
Time Frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Ankle-brachial index defined as the ratio of the blood pressure at the ankle to the blood pressure in the upper arm
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Variation in quality of life assessed by Walk Impairment Questionnary between randomization and 1, 6, 12 months.
Time Frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)

a questionnaire for evaluating walking impairment in patients

Parameters:

  • difficulty walking a distance during the past month
  • difficulty walking at a certain speed during the past month
  • symptoms associated with walking impairment
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Variation in quality of life assessed by EQ5D scores between randomization and 1, 6, 12 months.
Time Frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
overall score on a numeric scale "check the box that best describes your health today", 5 themes (mobility, autonomy of the person, common activities, pain / discomfort, anxiety / depression)
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Limb Rescue Rate
Time Frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)

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.
University Hospital, Lille

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Abbott

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: Jonathan Sobocinski, MD,PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
June 16, 2020

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.
June 1, 2026

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.
June 1, 2026

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).
June 8, 2020

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.
June 15, 2020

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.
June 17, 2020

Study Record Updates

Last Update Posted (Estimated)

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.
December 23, 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.
December 16, 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.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 2018_88
  • 2019-A01055-52 (Other Identifier: ID-RCB number,ANSM)

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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