Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions (NCT04434586) | Clinical Trial Compass
RecruitingNot Applicable
Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions
France166 participantsStarted 2020-06-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.