Cohort of patients with severe leg artery blockage undergoing surgery
Official title: Prospective Cohort of Patients With Critical Limb Ischemia Undergoing Revascularization
Run by Fondation Hôpital Saint-Joseph · NCT04312451 · Data updated 2026-11-12
This study looks at how well different surgical treatments work for hospitalized patients with severe leg artery blockage to help improve their chances of keeping their limbs and feeling better.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Fondation Hôpital Saint-Joseph Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | November 5, 2021 |
| Main results expected | June 25, 2026 |
| Study ends | June 25, 2027 |
| Registry record updated | October 3, 2022 |
| Trial ID | NCT04312451 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with critical lower limb ischemia characterized by severe pain or ulcers and specific hemodynamic measurements.
✕Probably not a fit
Patients who are under guardianship, deprived of their liberty, or who object to the use of their data for research will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients suffering from critical limb ischemia, a severe form of Peripheral Arterial Occlusive Disease that can lead to significant complications such as pain and foot ulcers. The study aims to assess the outcomes of revascularization procedures discussed in a multidisciplinary setting, where various specialists collaborate to determine the best surgical approach. Patients eligible for the study must be hospitalized and have specific hemodynamic criteria indicating severe ischemia. The goal is to improve limb salvage rates and overall patient prognosis.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies that enhance limb preservation and reduce mortality in patients with critical limb ischemia.
How similar studies have gone: Other studies have shown success in similar approaches to managing critical limb ischemia, indicating that this methodology is grounded in established clinical practices.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Man or Woman whose age is ≥ 18 years old * Patient with critical lower limb ischemia defined by the existence of decubitus pain or a wound (foot ulcer or gangrene) evolving for more than 2 weeks associated with hemodynamic criteria (systolic toe pressure \<30 mm Hg and / or systolic ankle pressure \<50 mm Hg). * Hospitalized in the vascular medicine department * Endovascular revascularization gesture discussed and confirmed by multidisciplinary staff Exclusion Criteria: * Patients under guardianship or curatorship * Patients deprived of their liberty * Patients objecting to the use of their data for this research
Where it's running
-
Groupe Hospitalier Paris Saint-Joseph
Paris, France Recruiting
Study contacts
- Principal investigator: Alexandra YANNOUTSOS, mD — Fondation Hôpital Saint-Joseph
- Study coordinator: Alexandra YANNOUTSOS, MD
- Email: ayannoutsos@hpsj.fr
- Phone: 144123568
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.