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Recruiting
NCT07512960
Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia After Distal Revascularization
Conditions: CLTI Defined as Rutherford Category 4 or 5
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 614
Sponsor: Fondation Hôpital Saint-Joseph
Location: Hospital Saint Joseph Paris Île-de-France Region
Summary
Chronic limb threatening ischemia (CLTI) is defined as ischemic foot pain at rest or non-healing foot wounds that is attributable to severe peripheral arterial disease (PAD).Revascularization is the cornerstone of therapy to relieve ischemic pain, prevent limb loss and preserve patient autonomy. Revascularization procedures often involve below-the-knee arterial disease in CLTI population. Dual antiplatelet therapy (DAPT, with aspirin, and clopidogrel) is recommended for at least 1-month after peripheral angioplasty. However, the exact duration of this DAPT remains controversial. Angioplasty of below-the-knee arteries is often followed by a longer period of DAPT, 3-months to one-year, due to a high risk of arterial thrombosis/stenosis.It will be the first trial on duration of DAPT in patients with below-the-knee angioplasty for CLTI, the end-stage of PAD
Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years
* Hospitalized patients with CLTI defined as Rutherford category 4 (ischemic rest pain) or 5 (minor tissue loss, non-healing ulcer, focal gangrene) evolving for \> 2 weeks + one or more abnormal hemodynamic parameters: ankle-brachial index (ABI) \
Source: ClinicalTrials.gov (NCT07512960). StuddyBuddy aggregates publicly available trial information.