Vascular registry pilot for peripheral arterial disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label randomized pilot enrolls patients aged 45 and older undergoing lower extremity endovascular revascularization for atherosclerotic peripheral arterial disease. All participants receive dual antiplatelet therapy (aspirin plus clopidogrel) for the first month, and those who consent at one month are randomized 1:1 (stratified by diabetes) to stop clopidogrel and continue single antiplatelet therapy versus continue dual therapy for an additional five months. Outcomes including target vessel patency, major adverse cardiovascular events (MACE), major adverse limb events (MALE), and bleeding events are followed for 12 months and data are collected through nested participation in the VQI-PVI registry.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age greater than or equal to 45 at time of enrollment
* Patient is scheduled for a PVI or has recently had a PVI in the last 30 days
* Patient data is being submitted to Fivos, who is acting as the data collection subcontractor for the VQI-PVI registry.
* Atherosclerotic vascular disease

Exclusion Criteria:

* Patients who cannot consent for themselves
* Allergy to Clopidogrel
* Patients unable to stop clopidogrel for other medical reasons
* Patients on dual pathway inhibition (DPI) with low dose rivaroxaban (2.5mg twice a day) that are unable to stop these medications
* Allergy to aspirin
* Nonatherosclerotic vascular disease
* Patients undergoing open bypass at the same time as the peripheral transcutaneous angioplasty
* Patients with high bleeding risk (HBR) defined as:

  * History of major bleeding, active bleeding disorder, severe renal impairment (CrCl \<30), concurrent anticoagulation, platelet count \<100,000
  * Recent stroke (within 6 months)
  * Current warfarin therapy or full dose therapeutic direct oral anticoagulants (DOAC).
* Patients unwilling or unable to comply with standard of care follow-up visits
* Pregnant women
* Prisoners

Where it's running

• Henry Ford Hospital
  Detroit, Michigan, United States Recruiting
• Corewell Health West
  Grand Rapids, Michigan, United States Recruiting

Study contacts

• Principal investigator: Vikram C Kashyap, MD — Corewell Health West
• Study coordinator: Stephen C Orey, MS
• Email: Stephen.orey@corewellhealth.org
• Phone: 6163916660

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.