NCT07076082

Vascular Trial Associated Registry Pilot

Vascular Trial Associated Registry Pilot: Antiplatelet Therapies for Patients Undergoing Lower Extremity Endovascular Revascularization

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Corewell Health West · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this investigator-initiated, multicenter, open label, randomized trial is to evaluate 1 month vs. 6 months of dual antiplatelet therapy (DAPT) in patients undergoing lower extremity endovascular revascularization. We hypothesize that extending dual antiplatelet therapy (DAPT) to six months, compared to one month, will improve patency rates of target vessels following peripheral vascular intervention (PVI) without significantly increasing complications, particularly bleeding events.

Detailed description

The Main Objective of this study is to create an investigator-initiated, multicenter, open label, randomized trial to evaluate 1 month vs. 6 months of DAPT in patients undergoing lower extremity endovascular revascularization. The randomization will be 1:1 within one strata (diabetes yes/no), using blocks of varying sizes. All patients will be on DAPT for one month. At the time of the one-month visit, eligible patients who consent will be randomized to single antiplatelet therapy (SAPT) indefinitely (Arm 1) or to DAPT for 5 more months (followed by SAPT) (Arm 2). Follow-up will continue for 12-months post-procedure and will include assessment of MACE and MALE, as well as adverse bleeding events. Data for this trial will be collected via nested participation in the VQI Peripheral Vascular Intervention (PVI) registry's existing Procedural and Follow-up data collection modules.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DRUG	Clopidogrel (Plavix) Pharmacogenetic Test Reagents	Dual antiplatelet therapy (DAPT), defined as the use of Clopidogrel (75 mg/day) (clopidogrel) and aspirin (81 mg or more/day). Single antiplatelet therapy (SAPT), defined as the use of aspirin (81 mg or more/day).

Timeline

• Start date: 2025-10-15
• Primary completion: 2027-10-30
• Completion: 2028-10-30
• First posted: 2025-07-21
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study