Vascular Trial Associated Registry Pilot for Peripheral Arterial Disease
This study is looking at whether taking dual antiplatelet therapy (DAPT) for 6 months, compared to 1 month, is better for people with Peripheral Arterial Disease (PAD) who have had a procedure to open blocked leg arteries (lower extremity endovascular revascularization). DAPT involves taking both clopidogrel (Plavix) and aspirin. All participants will take DAPT for one month. Then, some will continue DAPT for 5 more months, while others will switch to just aspirin. Researchers want to see if the longer DAPT keeps arteries open better without causing more bleeding. You may be eligible if you are at least 45 years old and are having or recently had this type of procedure. The study's current status is unclear.
- Study design
- This is an open-label, randomized study aiming to enroll 350 participants. Participants will be randomly assigned to one of two treatment groups.
- What's involved
- All patients will be on DAPT for one month. At the one-month visit, eligible patients will be randomized to either single antiplatelet therapy indefinitely or DAPT for 5 more months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after their procedure to assess outcomes and any side effects.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Vascular Trial Associated Registry Pilot
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Vikram C Kashyap, MD · PRINCIPAL_INVESTIGATOR · Corewell Health West
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- The proportion of patients eligible who are offered study enrollment1 year
Patients who undergo PVI that meet inclusion criteria and are offered enrollment.
- The proportion of eligible patients who consent to enrollment and randomization1 year
Patients who meet inclusion criteria and agree to participate in trial vs those that do not agree to participate in trial
- The proportion of enrolled patients who have the primary (composite) event of interest defined at 6 months6-months
The number of enrolled patients that have the occurrence of one of the following stroke, myocardial infarction, major amputation (above ankle), urgent revascularization (thrombolysis, endovascular therapy, or surgical bypass), or loss of patency of the target vessel.
- The proportion of enrolled patients who have the primary (composite) event of interest defined at 12 months1 year
The number of enrolled patients that have the occurrence of one of the following stroke, myocardial infarction, major amputation (above ankle), urgent revascularization (thrombolysis, endovascular therapy, or surgical bypass), or loss of patency of the target vessel.
- The numbers and proportions of patients who have each type of major event1 year
Of the enrolled patients that have a medical primary event how many individuals were in each category stroke, myocardial infarction, major amputation (above ankle), urgent revascularization (thrombolysis, endovascular therapy, or surgical bypass), or loss of patency of the target vessel.
- The proportions of patients who have major event status recorded at each observation time1 year
Major event status at 1, 6-months post PVI and 12-month post PVI