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

Not Applicable

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

• Registration Number: NCT04434586
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-15
• Study Start: 2020-06-16
• Study First Posted: 2020-06-17
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-24
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 166

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
angiography 2D	femoropopliteal revascularization for TASC C or TASC D lesion	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.
angiography 2D with OCT	femoropopliteal revascularization for TASC C or TASC D lesion	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
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.

Trial Locations

Locations (1)

Insitut Coeur-Poumon, CHU; 🇫🇷 Lille, France