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

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT04434586

Collaborator

Abbott (Industry)

166

Enrollment

Location

Arms

48.5

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Superficial Femoral Artery Stenosis Claudication Ischemic Leg	Device: femoropopliteal revascularization for TASC C or TASC D lesion	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

166 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions

Actual Study Start Date :

Jun 16, 2020

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Primary patency rate at 1 year. [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%.

Secondary Outcome Measures

Primary patency rate at 1 year. [at 1month (+/- 10days), 6months (+/- 1month)]
Target lesion revascularisation [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
Target vessel revascularisation [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.
cost-effectiveness analyses [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.

Other Outcome Measures

Rutherford scale considered ordinal variable [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).
Variation in Ankle Brachial Index between randomization and 1, 6, 12 months on the revascularized limb in the study. [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
Variation in quality of life assessed by Walk Impairment Questionnary between randomization and 1, 6, 12 months. [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
Variation in quality of life assessed by EQ5D scores between randomization and 1, 6, 12 months. [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)
Limb Rescue Rate [at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)