Coronary Artery DiseaseVEST IIINCT02511834
VEST III PMS Clinical Protocol
A study testing VEST External Support and Coronary Artery Bypass Surgery in people with Coronary Artery Disease, run by Vascular Graft Solutions Ltd. at 15 sites in 4 countries.
Trial summary
Post marketing surveillance (PMS) study. 200 patients will be enrolled in a prospective, multi center, randomized, two-arm, open label, and controlled, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo Coronary artery bypass grafting (CABG) with arterial grafting of IMA… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- VEST External Support and Coronary Artery Bypass Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 19 Oct 2015to Oct 2019
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for on-pump CABG on clinical grounds
- Two or more bypass vein grafts bypasses indicated as follows: one (1) for right coronary artery, 1 or more for left coronary arteries and IMA indicated for the LAD on clinical grounds
- Appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed
- Ability to give their informed written consent
- Ability and willingness to comply with study follow up requirements
- Patient is ≥ 18 and ≤ 80 years of age, and has Life expectancy ≥5 years
Who cannot join
- Concomitant non-CABG cardiac procedure
- Prior cardiac surgery
- Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
- 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, before randomization
- Severe vein varicosity
Show all 16Show fewer
- Prior debilitating stroke less than 1 year before surgery
- Severe renal dysfunction (Cr>2.0 mg/dL or >177 μmol/L)
- Women of child bearing age
- Concomitant life-threatening disease likely to limit life expectancy to less than 5 years
- Indication for Warfarin up to time of surgery
- Inability to tolerate or comply with required normal post-operative drug regimen (antiplatelet, statin and beta-blockers) that cannot adequately be controlled.
- inability to take aspirin
- Contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication
- Inability to comply with required follow-ups including angiographic and/or CT imaging methods.
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
Germany6 sites
German Heart Center
Berlin
Immanuel Hospital Bernau. Brandenburg Heart Center
Bernau
University Hospital of Cologne
Cologne
West-German Heart Center Essen University
Essen
University Medical Center Schleswig-Holstein
Lübeck
Krankenhaus der Barmherzigen Bruder
Trier
United Kingdom5 sites
Blackpool Victoria Hospital
Blackpool
University Hospitals Bristol
Bristol
The John Radcliffe Hospital
Oxford
Papworth Hospital
Papworth Everard, Cambridge
University Hospital Southampton
Southampton
Austria2 sites
Medical University of Innsbruck
Innsbruck
Medical University of Vienna
Vienna
Israel2 sites
Rambam - Health Care Campus
Haifa
Sheba Medical Center Hospital
Ramat Gan
About this study
Post marketing surveillance (PMS) study. 200 patients will be enrolled in a prospective, multi center, randomized, two-arm, open label, and controlled, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo Coronary artery bypass grafting (CABG) with arterial grafting of IMA to LAD, one saphenous vein graft (SVG) to the right territory and one or more SVGs to the left territory. Of all vein grafts, one will be selected randomly to receive treatment with VEST and another designated Control.
- Conditions
- Coronary Artery Disease
- Being tested
- VEST External Support, Coronary Artery Bypass Surgery
- 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.
VEST External SupportDevice
Coronary Artery Bypass SurgeryProcedure or surgery
Also called CABG
| Study group | Role | What they receive |
|---|---|---|
| VEST supported | Experimental | Vein graft supported by VEST Receives: Device: VEST External Support; Procedure: Coronary Artery Bypass Surgery |
| Control | Active comparator | Vein grafts unsupported by VEST Receives: Procedure: Coronary Artery Bypass Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Vein grafts with Fitzgibbon I patency score out of all grafts including occluded ones.
Perfect patency, no lumen irregularities. Rates out of all grafts including occluded ones.
Measured: 2 years
Secondary outcomes (4)
Intimal hyperplasia area
Sub group (IVUS) - Intimal hyperplasia (plaque+media) area [mm2] as assessed by IVUS
Measured: 2 years
MACCE
Composite of: All-cause mortality; Stroke; Myocardial infarction; Coronary revascularization
Measured: 2 years
Vein graft failure
Defined as ≥50% stenosis by QCA
Measured: 2 years
Early vein graft failure
Early vein graft failure, defined as >50% occlusion by CT Angio
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study start19 Oct 2015
- Primary completionJun 2019
- Study completionOct 2019
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascular Graft Solutions Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511834
- Sponsor's protocol ID
- CD0113
- Acronym
- VEST III
- Status last verified
- Jun 2020
- First submitted
- 25 Jul 2015
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Amin S, Werner RS, Madsen PL, Krasopoulos G, Taggart DP. Influence of external stenting on venous graft flow parameters in coronary artery bypass grafting: a randomized study. Interact Cardiovasc Thorac Surg. 2018 Jun 1;26(6):926-931. doi: 10.1093/icvts/ivy007.
PubMed 29373645
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VEST III PMS Clinical Protocol
- ClinicalTrials.gov ID
- NCT02511834
- Acronym / sponsor ID
- VEST III / CD0113
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Vascular Graft Solutions Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2015 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 30 Jul 2015 (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.
Post marketing surveillance (PMS) study. 200 patients will be enrolled in a prospective, multi center, randomized, two-arm, open label, and controlled, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo Coronary artery bypass grafting (CABG) with arterial grafting of IMA to LAD, one saphenous vein graft (SVG) to the right territory and one or more SVGs to the left territory. Of all vein grafts, one will be selected randomly to receive treatment with VEST and another designated Control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VEST supported | Experimental | Device: VEST External Support, Procedure: Coronary Artery Bypass SurgeryVein graft supported by VEST |
| Control | Active comparator | Procedure: Coronary Artery Bypass SurgeryVein grafts unsupported by VEST |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient scheduled for on-pump CABG on clinical grounds
- Two or more bypass vein grafts bypasses indicated as follows: one (1) for right coronary artery, 1 or more for left coronary arteries and IMA indicated for the LAD on clinical grounds
- Appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed
- Ability to give their informed written consent
- Ability and willingness to comply with study follow up requirements
Key exclusion criteria (16 listed)
- Concomitant non-CABG cardiac procedure
- Prior cardiac surgery
- Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
- 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, 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 |
|---|---|---|
| VEST External Support | Device | VEST supported |
| Coronary Artery Bypass SurgeryAlso: CABG | Procedure or surgery | Control, VEST supported |
Primary outcome
Proportion of Vein grafts with Fitzgibbon I patency score out of all grafts including occluded ones.
Time frame: 2 years
Perfect patency, no lumen irregularities. Rates out of all grafts including occluded ones.
4 secondary outcomes
Intimal hyperplasia area
Time frame: 2 years
MACCE
Time frame: 2 years
Vein graft failure
Time frame: 2 years
Early vein graft failure
Time frame: 6 months
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 26 Jun 2020.
- Derived from this study: PubMed 29373645Amin S, Werner RS, Madsen PL, Krasopoulos G, Taggart DP. Influence of external stenting on venous graft flow parameters in coronary artery bypass grafting: a randomized study. Interact Cardiovasc Thorac Surg. 2018 Jun 1;26(6):926-931. doi: 10.1093/icvts/ivy007.
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VEST External Support and Coronary Artery Bypass Surgery in people with Coronary Artery Disease, run by Vascular Graft Solutions Ltd. at 15 sites in 4 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 16 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 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, United Kingdom, Austria, Israel. 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?
Proportion of Vein grafts with Fitzgibbon I patency score out of all grafts including occluded ones. (time frame: 2 years). 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 NCT02511834, 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 26 Jun 2020; AzTrials last refreshed its copy on 3 Nov 2026.