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Active Not Recruiting NCT07597239

Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization

Conditions: Thrombosis, Arterial Occlusive Diseases, Thromboelastography (TEG), Peripheral Arterial Disease(PAD), Stent Thrombosis, Platelet Inhibition, PRU(Platelet Reactivity Unit)

Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 130
Sponsor: Massachusetts General Hospital

Location: Massachusetts General Hospital Boston Massachusetts

Summary

The goal of this clinical trial is to learn if a blood clotting test called thromboelastography with platelet mapping (TEG-PM) can guide blood-thinning medication decisions in adults 18 years and older with peripheral artery disease (PAD) who have undergone leg artery open or endovascular surgery. The main questions it aims to answer are: * Can TEG-PM results improve blood-thinning medication levels in participants at high risk for blood clots after surgery? * Can adjusting blood-thinning medications based on TEG-PM results lower the rate of blood clots forming in their revascularized leg after surgery? Participants will: * Have blood samples taken before surgery and at 1 week, 1 month, 2 months, 3 months, 6 months, and up to 9 months after surgery * Have blood-thinning medications (aspirin, clopidogrel, and/or ticagrelor) adjusted based on TEG-PM results during the first 3 months after surgery * Have one additional blood test to check if clopidogrel is working properly * Have their medical records reviewed for 6 months after their last visit to check on their health outcomes

Eligibility Criteria

Inclusion Criteria: * Patients requiring infrainguinal endovascular revascularization for peripheral atherosclerosis * Patients of age 60 or older Exclusion Criteria: * Planned open surgical revascularization (bypass grafting, endarterectomy) * Hybrid procedures involving a significant open surgical component * Contraindication to standard antiplatelet therapy * Pregnancy or breastfeeding * Inability to undergo serial venous blood sampling * Inability to provide informed consent * Technical failure to cross or treat the target lesion via an endovascular approach * Non-atherosclerotic pathology identified as primary etiology

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07597239). StuddyBuddy aggregates publicly available trial information.