Actively Recruiting

Phase 4
Age: 45Years +
All Genders
NCT07076082

Vascular Trial Associated Registry Pilot

Led by Corewell Health West · Updated on 2026-04-13

350

Participants Needed

2

Research Sites

158 weeks

Total Duration

On this page

Sponsors

C

Corewell Health West

Lead Sponsor

H

Henry Ford Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Vascular Trial Associated Registry Pilot

Who Can Participate

Age: 45Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than or equal to 45 at time of enrollment
  • Patient is scheduled for a peripheral vascular intervention (PVI) or has had one in the last 30 days
  • Patient data is being submitted to Fivos, the data collection subcontractor for the VQI-PVI registry
  • Diagnosis of atherosclerotic vascular disease
Not Eligible

You will not qualify if you...

  • Patients who cannot consent for themselves
  • Allergy to clopidogrel
  • Patients unable to stop clopidogrel for other medical reasons
  • Patients on dual pathway inhibition with low dose rivaroxaban (2.5 mg twice a day) who cannot stop these medications
  • Allergy to aspirin
  • Nonatherosclerotic vascular disease
  • Patients undergoing open bypass surgery at the same time as the peripheral angioplasty
  • Patients with high bleeding risk, including history of major bleeding, active bleeding disorders, severe kidney impairment (creatinine clearance <30), concurrent anticoagulation, or platelet count below 100,000
  • Recent stroke within 6 months
  • Current therapy with warfarin or full-dose direct oral anticoagulants
  • Patients unwilling or unable to comply with standard follow-up visits
  • Pregnant women
  • Prisoners

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Henry Ford Hospital

Detroit, Michigan, United States, 48202-2608

Not Yet Recruiting

2

Corewell Health West

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

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Research Team

S

Stephen C Orey, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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