Coronary Artery DiseaseVEST PivotalNCT03209609
VEST Venous Graft External Support Pivotal Study
A study testing VEST and Coronary artery bypass vein grafts in people with Coronary Artery Disease, run by Vascular Graft Solutions Ltd. at 17 sites in 2 countries.
Trial summary
Prospective, multi-center, randomized, within-subject-controlled , trial, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo SVG CABG with arterial grafting of IMA to LAD and two or more saphenous vein grafts. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- VEST and Coronary artery bypass vein grafts
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 9 Jan 2018to 25 Sep 2024
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation.
- Age 21 years or older.
- Planned and scheduled on-pump CABG.
- Two or more vein grafts to native vessels having at least 75% stenosis and comparable runoff.
- IMA graft indicated for the LAD. Additional arterial grafts may be considered based on practice guidelines.
- Appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed (without significant distal stenosis), as assessed by pre-operative cardiac angiography and verified by diameter gauging intraoperatively.
Who cannot join
- Concomitant non-CABG cardiac surgical procedure.
- Prior cardiac surgery.
- Emergency CABG surgery.
- Contraindication for on-pump CABG with cardioplegic arrest (e.g. severely calcified aorta).
- Calcification at the intended anastomotic sites, as assessed upon opening of the chest and before randomization.
- Severe vein varicosity as assessed after vein harvesting and before randomization.
Show all 13Show fewer
- History of clinical stroke within 3 months prior to randomization.
- Severe renal dysfunction (Cr>2.0 mg/dL).
- Documented or suspected untreated diffuse peripheral vascular disease such as: carotid stenosis or claudication of the extremities.
- Concomitant life-threatening disease likely to limit life expectancy to less than two years.
- Inability to tolerate or comply with required guideline-based post-operative drug regimen (antiplatelet plus statin) and/or inability to take aspirin.
- Inability to comply with required follow-ups including angiographic imaging methods (e.g. contrast allergy).
- Concurrent participation in an interventional (drug or device) trial.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States14 sites
University of Maryland Baltimore
Baltimore, Maryland, 21201
University of Virginia
Charlottesville, Virginia, 22908
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27705
Lutheran Hospital of Indiana
Fort Wayne, Indiana, 46804
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Southern California
Los Angeles, California, 90033
Mount Sinai St Luke's
New York, New York, 10025
New York Presbyterian Hospital/Columbia University Medical Center
New York, New York, 10032
Montefiore Medical Center
New York, New York, 10467
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Baylor Scott & White Research Institute, The Heart Hospital Baylor Plano
Plano, Texas, 75093
WakeMed Health & Hospitals
Raleigh, North Carolina, 27610
Mayo Clinic
Rochester, Minnesota, 55902
Canada3 sites
London Health Sciences Centre, University Hospital
London, Ontario, N6A 5A5
Institut de Cardiologie de Montréal
Montreal, Quebec, H1T 1C8
Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval
Québec, Quebec, G1V 4G5
About this study
Official title: A Multi-center, Randomized, Within-subject-controlled, Open Label Study of the Safety and Effectiveness of VEST, Venous External Support
Prospective, multi-center, randomized, within-subject-controlled , trial, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo SVG CABG with arterial grafting of IMA to LAD and two or more saphenous vein grafts. In each patient, one SVG bypass will be randomized to be supported by the VEST, while another will not be supported and serve as control. Thus, the full cohort will provide a basis for comparison between two sets of SVGs: A VEST supported set; and an unsupported set.
Read the detailed description
Clinical significance:
Coronary artery bypass grafting (CABG) remains the gold standard treatment for patients with multi-vessel coronary artery disease. Despite the proposed benefits of multiple arterial grafts, autologous saphenous vein grafts (SVGs) are still the most frequently used bypass conduits in CABG. Progressive SVG failure after CABG remains a key limitation to the long-term success of surgery.
Objective:
Coronary artery bypass grafting (CABG) remains the gold standard treatment for patients with multi-vessel coronary artery disease. Despite the proposed benefits of multiple arterial grafts, autologous saphenous vein grafts (SVGs) are still the most frequently used bypass conduits in CABG. Progressive SVG failure after CABG remains a key limitation to the long-term success of surgery.
Study design:
Prospective, multi-center, randomized, within-subject-controlled , trial, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo SVG CABG with arterial grafting of IMA to LAD and two or more saphenous vein grafts. In each patient, one SVG bypass will be randomized to be supported by the VEST, while another will not be supported and serve as control. Thus, the full cohort will provide a basis for comparison between two sets of SVGs: A VEST supported set; and an unsupported set.
- Conditions
- Coronary Artery Disease
- Being tested
- VEST, Coronary artery bypass vein grafts
- Keywords
- Coronary artery bypass
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VESTDevice
External support for vein grafts, cobalt chrome braid
Coronary artery bypass vein graftsProcedure or surgery
Bypass coronary arteries with autologous saphenous vein grafts
| Study group | Role | What they receive |
|---|---|---|
| VEST supported vein graft | Experimental | Coronary artery bypass vein graft supported with the VEST implant Receives: Device: VEST; Procedure: Coronary artery bypass vein grafts |
| Standard of care vein grafts | Active comparator | Coronary artery bypass vein grafts Receives: Procedure: Coronary artery bypass vein grafts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intimal hyperplasia area/graft occlusion
Intimal hyperplasia (plaque+media) area [mm2] as assessed by IVUS at 12 months. Occluded vessels are accounted for in the analysis of the primary endpoint
Measured: 1 year
Secondary outcomes (2)
Lumen diameter uniformity
Lumen diameter uniformity, assessed by angiography for each graft separately and expressed by the Fitzgibbon classification (22), on a 3-point ordinal scale
Measured: 1 year
vein graft failure
Graft Failure (≥50% stenosis) by cardiac angiography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start9 Jan 2018
- Primary completion29 Sep 2020
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In each patient, one SVG bypass will be randomized to be supported by the VEST, while another will not be supported and serve as control.
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascular Graft Solutions Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Center for Health Outcomes and Innovation Research
- Responsible party
- Sponsor
- Investigators
- John Puskas, MD, Principal investigator, Icahn School of Medicine at Mount SinaiDaniel Goldstein, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209609
- Sponsor's protocol ID
- CD0131
- Acronym
- VEST Pivotal
- Status last verified
- Feb 2025
- First submitted
- 4 Jul 2017
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Goldstein DJ, Puskas JD, Alexander JH, Chang HL, Gammie JS, Marks ME, Iribarne A, Vengrenyuk Y, Raymond S, Taylor BS, Yarden O, Orion E, Dagenais F, Ailawadi G, Chu MWA, DiMaio JM, Narula J, Moquete EG, O'Sullivan K, Williams JB Jr, Crestanello JA, Jessup M, Rose EA, Scavo V, Acker MA, Gillinov M, Mack MJ, Gelijns AC, O'Gara PT, Moskowitz AJ, Bagiella E, Voisine P. External Support for Saphenous Vein Grafts in Coronary Artery Bypass Surgery: A Randomized Clinical Trial. JAMA Cardiol. 2022 Aug 1;7(8):808-816. doi: 10.1001/jamacardio.2022.1437.
PubMed 35675092
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Within-subject-controlled, Open Label Study of the Safety and Effectiveness of VEST, Venous External Support
- ClinicalTrials.gov ID
- NCT03209609
- Acronym / sponsor ID
- VEST Pivotal / CD0131
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Vascular Graft Solutions Ltd.Industry (pharma, biotech, devices)
- Collaborators
- International Center for Health Outcomes and Innovation Research
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 6 Jul 2017 (actual)
- 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.
Prospective, multi-center, randomized, within-subject-controlled , trial, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo SVG CABG with arterial grafting of IMA to LAD and two or more saphenous vein grafts. In each patient, one SVG bypass will be randomized to be supported by the VEST, while another will not be supported and serve as control. Thus, the full cohort will provide a basis for comparison between two sets of SVGs: A VEST supported set; and an unsupported set.
Detailed description
Clinical significance:
Coronary artery bypass grafting (CABG) remains the gold standard treatment for patients with multi-vessel coronary artery disease. Despite the proposed benefits of multiple arterial grafts, autologous saphenous vein grafts (SVGs) are still the most frequently used bypass conduits in CABG. Progressive SVG failure after CABG remains a key limitation to the long-term success of surgery.
Objective:
Coronary artery bypass grafting (CABG) remains the gold standard treatment for patients with multi-vessel coronary artery disease. Despite the proposed benefits of multiple arterial grafts, autologous saphenous vein grafts (SVGs) are still the most frequently used bypass conduits in CABG. Progressive SVG failure after CABG remains a key limitation to the long-term success of surgery.
Study design:
Prospective, multi-center, randomized, within-subject-controlled , trial, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo SVG CABG with arterial grafting of IMA to LAD and two or more saphenous vein grafts. In each patient, one SVG bypass will be randomized to be supported by the VEST, while another will not be supported and serve as control. Thus, the full cohort will provide a basis for comparison between two sets of SVGs: A VEST supported set; and an unsupported set.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In each patient, one SVG bypass will be randomized to be supported by the VEST, while another will not be supported and serve as control.
| Arm | Type | Receives |
|---|---|---|
| VEST supported vein graft | Experimental | Device: VEST, Procedure: Coronary artery bypass vein graftsCoronary artery bypass vein graft supported with the VEST implant |
| Standard of care vein grafts | Active comparator | Procedure: Coronary artery bypass vein graftsCoronary artery bypass vein grafts |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation.
- Age 21 years or older.
- Planned and scheduled on-pump CABG.
- Two or more vein grafts to native vessels having at least 75% stenosis and comparable runoff.
- IMA graft indicated for the LAD. Additional arterial grafts may be considered based on practice guidelines.
Key exclusion criteria (13 listed)
- Concomitant non-CABG cardiac surgical procedure.
- Prior cardiac surgery.
- Emergency CABG surgery.
- Contraindication for on-pump CABG with cardioplegic arrest (e.g. severely calcified aorta).
- Calcification at the intended anastomotic sites, as assessed upon opening of the chest and before randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VESTExternal support for vein grafts, cobalt chrome braid | Device | VEST supported vein graft |
| Coronary artery bypass vein graftsBypass coronary arteries with autologous saphenous vein grafts | Procedure or surgery | Standard of care vein grafts, VEST supported vein graft |
Primary outcome
Intimal hyperplasia area/graft occlusion
Time frame: 1 year
Intimal hyperplasia (plaque+media) area [mm2] as assessed by IVUS at 12 months. Occluded vessels are accounted for in the analysis of the primary endpoint
2 secondary outcomes
Lumen diameter uniformity
Time frame: 1 year
vein graft failure
Time frame: 1 year
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 6 Feb 2025.
- Derived from this study: PubMed 35675092Goldstein DJ, Puskas JD, Alexander JH, Chang HL, Gammie JS, Marks ME, Iribarne A, Vengrenyuk Y, Raymond S, Taylor BS, Yarden O, Orion E, Dagenais F, Ailawadi G, Chu MWA, DiMaio JM, Narula J, Moquete EG, O'Sullivan K, Williams JB Jr, Crestanello JA, Jessup M, Rose EA, Scavo V, Acker MA, Gillinov M, Mack MJ, Gelijns AC, O'Gara PT, Moskowitz AJ, Bagiella E, Voisine P. External Support for Saphenous Vein Grafts in Coronary Artery Bypass Surgery: A Randomized Clinical Trial. JAMA Cardiol. 2022 Aug 1;7(8):808-816. doi: 10.1001/jamacardio.2022.1437.
- Individual participant dataSharing planned: No
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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.
John Puskas, MD principal investigator
Icahn School of Medicine at Mount Sinai
Daniel Goldstein, MD principal investigator
Montefiore Medical Center
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VEST and Coronary artery bypass vein grafts in people with Coronary Artery Disease, run by Vascular Graft Solutions Ltd. at 17 sites in 2 countries.
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 6 inclusion and 13 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 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada. 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?
Intimal hyperplasia area/graft occlusion (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03209609, which also lists 1 linked publication.
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 6 Feb 2025.