Not Yet RecruitingNot Applicable

Comprehensive Limb Evaluation and Arterial Revascularization With Toe Pressure Optimization Registry

France200 participantsStarted 2025-07-07

Plain-language summary

To address the heterogeneity of practices, better understand the outcomes of cricital limb theatening ischemia (CLTI) patients after endovascular interventions, and recognize effective endovascular options for infrapopliteal artery revascularization in CLTI, our prospective registry aims to tackle the critical question of whether intensive toe pressure evaluation, guiding repeat revascularization using predetermined thresholds (\<30 mmHg or decrease \>10% from immediate postoperative assessment), could optimize outcomes in patients with CLTI.

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: * Age ≥ 18 years * Rutherford category 4 or 5 * Wounds limited to toes or forefoot with a salvageable limb * Infrapopliteal lesions (infra-popliteal arteries) with \>70% stenosis upon visual assessment during initial angiography Exclusion Criteria: * Previous or planned major amputation of the target limb * Untreated aortoiliac/femoropopliteal stenotic disease limiting flow * History of infrapopliteal bypass on the target limb * Failure of percutaneous transluminal angioplasty of the target limb (technical failure) * Absence of angiographic evidence of a patent artery below the ankle ("desert foot") * Lesions located inside or near an arterial aneurysm * Life expectancy \< 1 year * Acute limb ischemia * Septicemia or bacteremia

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.

What they're measuring

Toe pressure with Systolic pressure measurement device

Timeframe: Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Trial details

NCT IDNCT07014072

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-07

Contact for this trial

Eric DUCASSE, MD, PhD

+335 56 79 55 25 eric.ducasse@chu-bordeaux.fr

View on ClinicalTrials.gov More Critical Limb Ischemia (CLI) trials