Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

More Critical Limb Ischemia trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorFondation Hôpital Saint-Joseph
Academic / other
Locations1 site (Paris)
StatusRecruiting
StartedNovember 5, 2021
Main results expectedJune 25, 2026
Study endsJune 25, 2027
Registry record updatedOctober 3, 2022
Trial IDNCT04312451 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.