Outcomes of Rivaroxaban and Aspirin in PAD After Endovascular Revascularization

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Assessing the outcomes of using Rivaroxaban plus Aspirin in patients with Lower Extremity Peripheral Arterial Disease after Endovascular Revascularization

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: Aspirin; Rivaroxaban

Criteria

Inclusion Criteria:

• Age ≥40 .

• Documented moderate to severe symptomatic lower extremity atherosclerotic peripheral artery disease.

• Technically successful peripheral revascularization distal to the external iliac artery for symptomatic PAD (Peripheral artery disease) within the last 10 days prior to randomization.

• Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.

• Subject has provided written informed consent.

Exclusion Criteria:

• Subject's age less than 40.

• Patients undergoing revascularization for asymptomatic PAD or mild claudication without functional limitation of the index leg.

• Imminent or foreseeable amputation.

• Subject already had a major amputation on the affected extremity

• Subject has emergent ischemic lesion [such as gas forming infection].

• Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre- treatment.

• Subject is not in the position to be primarily revascularized or refuses surgery.

• Acute embolic ischemia.