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

Official Title:

Understanding Peripheral Restenosis: Genomic and Proteomic Determinants of Vascular Intervention

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Observational [Patient Registry] 18 Years and older Vascular Cures VCures
NCT02180373
Enrolling patients

Study Design:


Principal Investigator

Professor and Chief,
Division of Vascular & Endovascular Surgery
Edwin J. Wylie, M.D. Chair in Vascular Surgery
Co-Director, UCSF Heart and Vascular Center
Co-Director, UCSF Center for Limb Preservation
Director, Vascular Surgery Integrated Residency Program

Clinical Research Coordinator

UCSF Medical Center at Parnassus
415.353.4379 Phone
415.353.4370 Fax

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).

Eligibility

Inclusion Criteria:

     1. Age of at least 18 years.
     2. Provision of written informed consent for biospecimen storage, broad genetic and
         proteomic analysis of tissues, without restrictions, and correlation with clinical
         outcome data.
     3. Willingness to undergo all study collection procedures and sample analyses
         . VG BYPASS COHORT
1. Patient requires placement of an infrainguinal vein bypass graft for the treatment of
chronic peripheral artery occlusive disease (PAD). Disabling claudication or critical limb
ischemia are acceptable indications.
2. Adequate vein conduit (saphenous vein or alternative vein/spliced vein grafts) for
bypass available based on preoperative surgical and/or ultrasound assessment.
SFA COHORT:

     1. Patient requires placement of a superficial femoral artery stent for the treatment of
         chronic peripheral artery occlusive disease (PAD). Disabling claudication or critical
         limb ischemia are acceptable indications.
     2. TransAtlantic Intersociety Consensus (TASC) A-C lesions (must be >70% by visual
         estimate) amenable to bare metal or drug-eluting stent placement. Stent manufacturer
         is at the discretion of the treating physician; stents to be used must be commercially
         available and, if drug-eluting, FDA-approved for SFA use .
     3. Must have at least one patent outflow vessel to the foot.
Exclusion Criteria:

     1. Anticipated life expectancy less than 2 years.
     2. Undergoing active treatment for advanced malignancy (e.g. metastatic disease).
     3. On immunosuppressive therapy for solid organ transplant or other indications.
     4. Known or suspected hypercoagulable state.
     5. Unable or unwilling to be compliant with the follow-up assessments.
VG BYPASS COHORT

     1. Use of any non-autogenous conduit or revision of a pre-existing graft.
     2. Bypass performed for other than chronic atherosclerotic occlusive disease (e.g.
         arteritis, aneurysm, acute limb ischemia or trauma).
     3. Combined endovascular intervention during same procedure (i.e. hybrid procedure)
         except for treatment of ipsilateral TASC A/B iliac disease.
SFA STENT COHORT

     1. Stent placement performed for other than chronic atherosclerotic occlusive disease
         (e.g. arteritis, aneurysm, acute limb ischemia, or trauma).
     2. TASC D disease (total SFA occlusion or occlusion with severe calcification not
         amenable to stent placement).
     3. Previous SFA stent placement.
     4. Use of stent graft.
     5. Lesions requiring stent placement > 1cm below the tibial plateau.
     6. Known or suspected allergy to nickel.
     7. Pregnancy.

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.

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 7/6/2018. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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