Cohort of patients with severe leg artery blockage undergoing surgery
Prospective Cohort of Patients With Critical Limb Ischemia Undergoing Revascularization
Fondation Hôpital Saint-Joseph · NCT04312451
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Hôpital Saint-Joseph (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT04312451 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown success in similar approaches to managing critical limb ischemia, indicating that this methodology is grounded in established clinical practices.
Eligibility criteria
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 this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Critical Limb Ischemia