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NCT04312451: CLI ENDOVASC
Prospective Cohort of Patients With Critical Limb Ischemia Undergoing Revascularization
trial in Critical Limb Ischemia in 300 participants. Currently enrolling.
25 June 2026
Quick facts
| Lead sponsor | Fondation Hôpital Saint-Joseph |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 5 November 2021 |
| Primary completion | 25 June 2026 |
| Estimated completion | 25 June 2027 |
| Sites | 1 location across France |
Conditions studied
- Critical Limb Ischemia — all drugs for Critical Limb Ischemia →
Sponsor
Fondation Hôpital Saint-Joseph — full company profile →
Who can join
18 and older, any sex, with Critical Limb Ischemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04312451
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
Other recruiting trials for Critical Limb Ischemia
Currently open trials in the same condition.
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- NCT06434194 — Serrantor OCT Study · NA · recruiting
- NCT06482892 — TP03HN106 in Patients With Critical Limb Ischemia · Phase 2 · recruiting
- NCT06296576 — Acceleration Time Assessment for Prediction of Critical Limb Ischemia · recruiting
- NCT06075940 — Evaluation of the MAGNITUDE® Bioresorbable Drug-Eluting Scaffold in the Treatment of Patients With Below the Knee Diseas · NA · recruiting
Other Fondation Hôpital Saint-Joseph trials
Trials by the same sponsor.
- NCT07512960 — Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia After Distal Revascularization · Phase 3 · not yet recruiting
- NCT07512908 — Study of Factors Influencing the Dynamics of Colonisation and Decolonisation of the Digestive Tract by Clostridioides Di · NA · not yet recruiting
- NCT07512830 — Evaluation of the Benefits of Hypnosis During Transoesophageal Echocardiography · NA · recruiting
- NCT07348081 — Real World Evidence to Assess the Value of a Digital Care Coordination and Monitoring Program for Supporting Caregivers · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04312451 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondation Hôpital Saint-Joseph
- Last refreshed: 3 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04312451.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing