NCT02180373

PREDICT-PVI Understanding Peripheral Restenosis: Genomic and Proteomic Determinants of Vascular Intervention

Understanding Peripheral Restenosis: Genomic and Proteomic Determinants of Vascular Intervention

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 67 (actual)
• Sponsor: Vascular Cures · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall goal of this multicenter collaborative research study is to identify genetic, proteomic, and/or lipidic (lipidomic) biomarkers associated with the outcomes of lower extremity revascularization in patients with advanced peripheral artery disease (PAD).

Detailed description

Vascular surgeons at 10-15 centers will ultimately be involved. Patients who are already undergoing physician-specified intervention and follow up, and meet enrollment criteria, will participate in the study. The PREDICT study includes two independent arms to assess restenosis - peripheral vein graft (VG) bypass surgery and endovascular (angioplasty and superficial femoral artery (SFA) stenting). In broad outline, approximately 1,000 patients will be enrolled for each arm, with clinical follow-up out to two years. Demographic, clinical, and procedural data will be collected at baseline. Clinical and imaging data will be obtained over the follow up period in accordance with standard post-procedural surveillance practices (1, 3, 6, 12, 18, 24 months). Blood samples will be obtained for genomic DNA and plasma biomarkers at 3 time points - baseline, 1 month and 6 months. The baseline samples will provide key information about patients with advanced PAD, often correlated with significant coronary disease. Data is entered by clinical coordinators into electronic case report forms in the Remedy Informatics database controlled by Vascular Cures. No PHI is included. Paper copies are maintained at the site. Registry data elements were developed with the study PI at University of California at San Francisco (UCSF). The Vascular Cures project manager reviews the database on a monthly basis to insure that case report forms (CRFs) are being completed appropriately and manage the data. Minor data omissions will be ignored; coordinators will be asked to re-submit for any major omissions. Site coordinators are responsible for managing all activities related to patients.

Conditions

• Peripheral Artery Disease

Timeline

• Start date: 2012-12-01
• Primary completion: 2017-07-28
• Completion: 2017-07-28
• First posted: 2014-07-02
• Last updated: 2021-10-05

Locations

4 sites across 1 country: United States