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

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: Recruiting
• Conditions: Ischemic Leg; Claudication; Superficial Femoral Artery Stenosis
• Intervention / Treatment: Device: femoropopliteal revascularization for TASC C or TASC D lesion

• Study Type: Interventional
• Enrollment (Estimated): 166
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan Sobocinski, MD,PhD; Phone Number: 0320445911; Email: jonathan.sobocinski@chru-lille.fr

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Primary patency rate at 1 year.	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

Outcome Measure	Measure Description	Time Frame
Primary patency rate at 1 year.		at 1month (+/- 10days), 6months (+/- 1month)
Target lesion revascularisation	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	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	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

Outcome Measure	Measure Description	Time Frame
Rutherford scale considered ordinal variable	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.	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.	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.	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		at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Abbott
• Investigators: Principal Investigator: Jonathan Sobocinski, MD,PhD, University Hospital, Lille

Publications and helpful links

General Publications

• Dubosq M, Goueffic Y, Duhamel A, Denies F, Dervaux B, Goyault G, Sobocinski J. Optical Coherence Tomography Contribution Assessment in the Revascularization of Long Femoropopliteal Occlusive Lesions (TASC C and D): A Randomized Trial. Ann Vasc Surg. 2021 Jan;70:362-369. doi: 10.1016/j.avsg.2020.06.061. Epub 2020 Jul 4.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: endovascular treatment; optical coherence tomography (OCT); femoral recanalization; TASC-C,; TASC-D
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Intermittent Claudication
• Other Study ID 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