NCT04312451 Prospective Cohort of Patients With Critical Limb Ischemia Undergoing Revascularization
| NCT ID | NCT04312451 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Hôpital Saint-Joseph |
| Condition | Critical Limb Ischemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-11-05 |
| Primary Completion | 2026-06-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2021-11-05 with a primary completion date of 2026-06-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Peripheral Arterial Occlusive Disease is associated with a high risk of cardiovascular events. The critical ischemia stage represents the most severe stage of Peripheral Arterial Occlusive Disease, associated with decubitus pain and / or foot ulceration. The severity of this arterial involvement involves functional prognosis of the lower limb with a high risk of amputation, and the vital prognosis of the patient. In these patients, the rate of amputation and mortality at 1 year can reach 20%. Therefore, the goal of management in a multidisciplinary setting is limb salvage and improvement of the patient's vital prognosis. In the vascular medicine department, the indication and modalities of the revascularization procedure are discussed in a multidisciplinary consultation meeting. Surgical revascularization by distal bypass requires venous material that can be used, a receiving artery without diffuse lesions, in direct continuity with the arterial network of the foot, and the absence of co-morbidities against general anesthesia. With the modernization and development of endovascular equipment dedicated to the hamstrings, the interventional radiology techniques in the management of critical ischemia allow the treatment of one or more arterial axes as well as a very distal revascularization in the arteries. of the foot with less morbidity-mortality compared to surgery, especially in patients the most fragile patients. Since 2013, the endovascular revascularization procedures performed by the interventional radiology team have been an integral part of the management of patients with peripheral arterial disease of the lower limbs monitored in the vascular medicine department. The hospital is therefore a privileged place to observe the long-term impact of this medical care on the future of patients with different stages of severity of arterial disease. The objective of this prospective study is to assess the vital prognosis, limb salvage and associated prognostic factors in patients with critical ischemia supported by endovascular revascularization in the vascular medicine service of the GHPSJ. The objective of this cohort study is to build a database on critical ischemia in hospitalized patients, to judge the management, monitoring and prognosis of patients.
Eligibility 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
Contact & Investigator
Alexandra YANNOUTSOS, mD
PRINCIPAL INVESTIGATOR
Fondation Hôpital Saint-Joseph
Frequently Asked Questions
Who can join the NCT04312451 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Limb Ischemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04312451 currently recruiting?
Yes, NCT04312451 is actively recruiting participants. Contact the research team at ayannoutsos@hpsj.fr for enrollment information.
Where is the NCT04312451 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04312451 clinical trial?
NCT04312451 is sponsored by Fondation Hôpital Saint-Joseph. The principal investigator is Alexandra YANNOUTSOS, mD at Fondation Hôpital Saint-Joseph. The trial plans to enroll 300 participants.