NCT07076082 Vascular Trial Associated Registry Pilot
| NCT ID | NCT07076082 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Corewell Health West |
| Condition | Peripheral Arterial Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 350 participants in total. It began in 2025-10-15 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Vikram C Kashyap, MD
PRINCIPAL INVESTIGATOR
Corewell Health West
Frequently Asked Questions
Who can join the NCT07076082 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07076082 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07076082 currently recruiting?
Yes, NCT07076082 is actively recruiting participants. Contact the research team at Stephen.orey@corewellhealth.org for enrollment information.
Where is the NCT07076082 trial being conducted?
This trial is being conducted at Detroit, United States, Grand Rapids, United States.
Who is sponsoring the NCT07076082 clinical trial?
NCT07076082 is sponsored by Corewell Health West. The principal investigator is Vikram C Kashyap, MD at Corewell Health West. The trial plans to enroll 350 participants.