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

NCT02180373 | Completed

• 1 other identifier: VCures
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• Revascularization required

  observation is to identify biomarkers of vascular healing

  2 years

Study Arms (2)

vein graft bypass

patients who have had peripheral bypass

SFA stent

Patients who have had SFA stenting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced peripheral artery disease already undergoing treatment by participating vascular surgeons, who are either having vein graft (VG) bypass or superficial femoral artery (SFA) stenting. These procedures are unrelated to this study. Enrollment is at the discretion of the participating vascular surgeon in addition to meeting inclusion criteria.

You may qualify if:

• Age of at least 18 years.
• Provision of written informed consent for biospecimen storage, broad genetic and proteomic analysis of tissues, without restrictions, and correlation with clinical outcome data.
• Willingness to undergo all study collection procedures and sample analyses
• VG BYPASS COHORT
• \. 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.
• \. Adequate vein conduit (saphenous vein or alternative vein/spliced vein grafts) for bypass available based on preoperative surgical and/or ultrasound assessment.
• SFA COHORT:
• 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.
• 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 .
• Must have at least one patent outflow vessel to the foot.

You may not qualify if:

• Anticipated life expectancy less than 2 years.
• Undergoing active treatment for advanced malignancy (e.g. metastatic disease).
• On immunosuppressive therapy for solid organ transplant or other indications.
• Known or suspected hypercoagulable state.
• Unable or unwilling to be compliant with the follow-up assessments.
• VG BYPASS COHORT
• Use of any non-autogenous conduit or revision of a pre-existing graft.
• Bypass performed for other than chronic atherosclerotic occlusive disease (e.g. arteritis, aneurysm, acute limb ischemia or trauma).
• Combined endovascular intervention during same procedure (i.e. hybrid procedure) except for treatment of ipsilateral TASC A/B iliac disease.
• SFA STENT COHORT
• Stent placement performed for other than chronic atherosclerotic occlusive disease (e.g. arteritis, aneurysm, acute limb ischemia, or trauma).
• TASC D disease (total SFA occlusion or occlusion with severe calcification not amenable to stent placement).
• Previous SFA stent placement.
• Use of stent graft.
• Lesions requiring stent placement \> 1cm below the tibial plateau.

Sponsors & Collaborators

• Vascular Cures: lead

Study Sites (4)

UCSF

San Francisco, California, 94143, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Puget Sound VA

Seattle, Washington, 98108, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood from 3 timepoints plus 1 tube of plasma; for vein graft bypass arm, otherwise discarded vein tissue

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Michael S Conte, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 2, 2014
• Study Start: December 1, 2012
• Primary Completion: July 28, 2017
• Study Completion: July 28, 2017
• Last Updated: October 5, 2021

Record last verified: 2021-10

Locations

US (4)