PREDICT-PVI Understanding Peripheral Restenosis: Genomic & Proteomic

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02180373
Study type	Observational [Patient Registry]
Source	Vascular Cures
Contact
Status	Completed
Phase
Start date	December 2012
Completion date	July 28, 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms