Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia After Distal Revascularization

You may not qualify if:

• PAD Rutherford category 0, 1, 2, 3 or 6 (Rutherford 6 defined as severe
• ischemic ulcers or foot gangrene exceeding the digits)
• Acute limb ischemia within one month prior to the qualifying revascularization
• Platelet count \< 100x109/L
• Need for dual antiplatelet therapy for other reason than PAD
• Need for concomitant treatment with anticoagulant (VKA or DOAC \[except low dose rivaroxaban 2.5 mg x 2\])
• Known allergy or hypersensitivity to aspirin/clopidogrel
• Severe hepatic impairment or any known hepatic disease associated with coagulopathy or bleeding risk;
• Any condition requiring dialysis or renal replacement therapy or a renal impairment at screening assessed with an estimated glomerular filtration rate \<15 mL/min/1.73 m2 (if a patient's eGFR is \<30 mL/min/1.73 m2 prior to the procedure, it must remain \>15 mL/min/1.73 m2 72 hours after the procedure to enroll and randomize the patient);
• Any medically documented history of intracranial hemorrhage, stroke, or transient ischemic attack (TIA);
• Known active malignancy (as determined through review of medical history), excluding local skin cancer (basal or squamous cell carcinoma);
• Poorly controlled diabetes (at the discretion of the investigator);
• Severe uncontrolled hypertension (at the discretion of investigator);
• Previous (within 30 days) or concomitant participation in another clinical interventional study (drug or device)
• Close affiliation with the investigational site; e.g., a close relative of the investigator, dependent person (e.g., employee or student of the investigational site)
• +4 more criteria