Peripheral Artery DiseaseNCT02180373
PREDICT-PVI Understanding Peripheral Restenosis: Genomic and Proteomic Determinants of Vascular Intervention
An observational study of Peripheral Artery Disease, run by Vascular Cures at 4 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- How many people
- 67 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2012to 28 Jul 2017
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- 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.
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- 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.
Who cannot join
- 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
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- 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.
- Known or suspected allergy to nickel.
- Pregnancy.
- -
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Florida
Gainesville, Florida, 32611
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
UCSF
San Francisco, California, 94143
Puget Sound VA
Seattle, Washington, 98108
About this study
Official title: Understanding Peripheral Restenosis: Genomic and Proteomic Determinants of Vascular Intervention
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).
Read the 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
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| vein graft bypass | patients who have had peripheral bypass | |
| SFA stent | Patients who have had SFA stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revascularization required
observation is to identify biomarkers of vascular healing
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startDec 2012
- Primary completion28 Jul 2017
- Study completion28 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Vascular Cures
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael S Conte, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180373
- Sponsor's protocol ID
- VCures
- Status last verified
- Oct 2021
- First submitted
- 30 Jun 2014
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Peripheral Restenosis: Genomic and Proteomic Determinants of Vascular Intervention
- ClinicalTrials.gov ID
- NCT02180373
- Acronym / sponsor ID
- VCures
- Conditions
- Peripheral Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Vascular CuresUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- 28 Jul 2017 (actual)
- Study completion
- 28 Jul 2017 (actual)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vein graft bypass | – | –patients who have had peripheral bypass |
| SFA stent | – | –Patients who have had SFA stenting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Revascularization required
Time frame: 2 years
observation is to identify biomarkers of vascular healing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S Conte, MD principal investigator
University of California, San Francisco
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, run by Vascular Cures at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revascularization required (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.