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VEST for Coronary Artery Disease (VEST Pivotal Trial)
N/A
Waitlist Available
Led By Daniel Goldstein, MD
Research Sponsored by Vascular Graft Solutions Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 21 years or older.
Planned and scheduled on-pump CABG.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up annually over 5 years
Awards & highlights
VEST Pivotal Trial Summary
This trial will compare the effects of VEST on saphenous vein grafts in patients with multi vessel atherosclerotic coronary artery disease.
Who is the study for?
This trial is for adults over 21 with multi-vessel coronary artery disease who are scheduled for on-pump bypass surgery using a vein graft. They must have at least two veins suitable for grafting and not have had previous heart surgeries, emergency procedures, or conditions that could limit life expectancy to under two years.Check my eligibility
What is being tested?
The study tests the VEST device's effectiveness in supporting saphenous vein grafts during coronary artery bypass surgery. Each patient will have one vein supported by VEST and another untreated as a control, allowing direct within-subject comparison.See study design
What are the potential side effects?
While specific side effects of the VEST device aren't detailed here, typical risks may include infection at the surgical site, inflammation around the graft area, blood clots in the treated veins, or reactions to materials used in VEST.
VEST Pivotal Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older.
Select...
I am scheduled for a heart bypass surgery using a heart-lung machine.
Select...
I have two or more vein grafts with significant narrowing.
Select...
My heart's arteries are big enough and healthy for the procedure, as confirmed by tests.
VEST Pivotal Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ annually over 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~annually over 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intimal hyperplasia area/graft occlusion
Secondary outcome measures
Lumen diameter uniformity
vein graft failure
Other outcome measures
MACCE
VEST Pivotal Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: VEST supported vein graftExperimental Treatment2 Interventions
Coronary artery bypass vein graft supported with the VEST implant
Group II: Standard of care vein graftsActive Control1 Intervention
Coronary artery bypass vein grafts
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VEST
2015
N/A
~80
Find a Location
Who is running the clinical trial?
Vascular Graft Solutions Ltd.Lead Sponsor
5 Previous Clinical Trials
289 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
229 Patients Enrolled for Coronary Artery Disease
International Center for Health Outcomes and Innovation ResearchOTHER
5 Previous Clinical Trials
742 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
298 Patients Enrolled for Coronary Artery Disease
Daniel Goldstein, MDPrincipal InvestigatorMontefiore Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe varicose veins identified after a vein was taken for surgery.I have not had a stroke in the last 3 months.I have or might have untreated blood vessel problems like narrowed arteries or leg pain when walking.I cannot take aspirin or follow the post-surgery drug plan.I am scheduled for a heart bypass surgery using a heart-lung machine.I have two or more vein grafts with significant narrowing.I need a specific artery graft for my heart.There is calcium buildup at the place where two blood vessels are connected.I am undergoing a heart surgery that is not a bypass.I have had heart surgery before.I have had emergency coronary artery bypass surgery.I cannot have heart bypass surgery due to a high-risk condition like a severely calcified aorta.I am 21 years old or older.My kidney function is severely impaired.My heart's arteries are big enough and healthy for the procedure, as confirmed by tests.I do not have a severe illness that would limit my life to under two years.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of care vein grafts
- Group 2: VEST supported vein graft
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants still being accepted for this research endeavor?
"Clinicaltrials.gov suggests that no new applicants are being sought for this clinical trial, which began on September 1st 2018 and was last edited May 8th 2022. However, there exist 545 other medical trials actively seeking patients at the moment."
Answered by AI
Are there any participating locations conducting this clinical experiment in the city?
"At present, 17 distinct clinical trial sites across the country are available for patient enrollment. These locations include Baltimore, Fort Wayne and Lebanon as well as 14 other locales. To reduce travel commitments if you decide to join this research project, it is advised to choose the site closest to your home."
Answered by AI
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