Vascular Trial Associated Registry Pilot (NCT07076082) | Clinical Trial Compass
RecruitingPhase 4
Vascular Trial Associated Registry Pilot
United States350 participantsStarted 2025-10-15
Plain-language 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.
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of patients eligible who are offered study enrollment
Timeframe: 1 year
2
The proportion of eligible patients who consent to enrollment and randomization
Timeframe: 1 year
3
The proportion of enrolled patients who have the primary (composite) event of interest defined at 6 months
Timeframe: 6-months
4
The proportion of enrolled patients who have the primary (composite) event of interest defined at 12 months
Timeframe: 1 year
5
The numbers and proportions of patients who have each type of major event
Timeframe: 1 year
6
The proportions of patients who have major event status recorded at each observation time