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

University Hospital, Lille1 site in 1 country166 target enrollmentJune 16, 2020

ConditionsSuperficial Femoral Artery Stenosis Claudication Ischemic Leg

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Superficial Femoral Artery Stenosis
Sponsor: University Hospital, Lille
Enrollment: 166
Locations: 1
Primary Endpoint: Primary patency rate at 1 year.
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 16, 2020

End Date

June 1, 2026

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Lille

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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%.

Secondary Outcomes

Target vessel revascularisation(at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months))
Primary patency rate at 1 year.(at 1month (+/- 10days), 6months (+/- 1month))
Target lesion revascularisation(at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months))
cost-effectiveness analyses(at 12 months (+/- 2months))