Antiplatelet therapy following peripheral endovascular interventio

Not Applicable

Completed

• Conditions: Peripheral arterial disease; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12618000523202
• Lead Sponsor: Aneurin Bevan University Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-10
• Study Completion: 2020-01-31
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 516

Inclusion Criteria

•Patients undergoing primary angioplasty or stenting with bare metal or drug-eluting stents of the infra-renal aorta; common or external iliac arteries; common, superficial or deep femoral artery; popliteal artery; tibio-peroneal trunk; anterior or posterior tibial artery or peroneal artery or any pedal artery for stenotic or occlusive peripheral arterial disease
•Patients undergoing primary angioplasty or stenting of a stenosis in a surgical bypass graft running between two of the included arteries mentioned above
•Patients already included in the study by virtue of treatment of the contralateral limb, who subsequently undergo endovascular therapy to the other leg

Exclusion Criteria

•Patients undergoing treatment for aneurysmal disease, or for a complication of treatment of aneurysmal disease
•Lesions treated with covered stent grafts
•Patients already recruited into the study and undergoing repeated endovascular therapy to the same limb
•Patients undergoing treatment proximal to the infra-renal aorta, to the upper limb, head and next vessels, mesenteric or renal vessels
•Patients undergoing diagnostic angiogram only, with no attempt made to perform angioplasty
•Patients undergoing intra-arterial embolectomy, thrombectomy or thrombolysis, other than those where this is commenced immediately following primary angioplasty or stenting in order to treat a complication.
•Venous procedures (e.g. stenting of veins following DVT)
•Angioplasty or stenting of arterio-venous fistulas
•Treatment of arterio-venous malformations
•Patients receiving therapeutic anticoagulation in the form of therapeutic dose low molecular weight heparin; or warfarin with a target international normalised ratio of 2.0 or more; or a direct oral anticoagulant such as apixaban, dabigatran or rivaroxaban at therapeutic dosage.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amputation-free survival (efficacy outcome), as assessed by linkage to electronic medical records[Assessed retrospectively at date of study commencement, which will be a minimum of 12 months following the index procedure.];Freedom from major bleeding (safety outcome), defined as bleeding events requiring either presentation to the emergency room or hospital admission as assessed by linkage to electronic medical records[Assessed retrospectively at date of study commencement, which will be a minimum of 12 months following the index procedure.]