Coronary Heart DiseaseVESTNCT01415245
Vein External Support Trial
A study testing Fluent (VGS Fluent external support device) in people with Coronary Heart Disease, run by Vascular Graft Solutions Ltd. at 3 sites in United Kingdom.
Trial summary
Prospective, multi-center, randomized, controlled pilot study to demonstrate the safety and effectiveness of the VGS Fluent external support device, supporting saphenous vein grafts in patients with coronary heart disease. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Fluent (VGS Fluent external support device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Oct 2011to Dec 2013
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Primary Inclusion Criteria:
- Patient scheduled for on-pump CABG on clinical grounds
- Vein grafts indicated for right and circumflex coronary arteries and LIMA indicated for the LAD on clinical grounds
- Native circumflex and right coronary arteries have at least one stenosis in each vessel> 75%
Primary Exclusion Criteria:
- Concomitant non-CABG cardiac procedure
- Prior peripheral vascular or cardiac surgery
- Emergency CABG surgery (cardiogenic shock, inotrophic pressure support, IABP)
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Royal Brompton Hospital
London
Harefield Hospital
Middlesex
The John Radcliffe Hospital
Oxford
About this study
Prospective, multi-center, randomized, controlled pilot study to demonstrate the safety and effectiveness of the VGS Fluent external support device, supporting saphenous vein grafts in patients with coronary heart disease.
- Conditions
- Coronary Heart Disease
- Being tested
- Fluent (VGS Fluent external support device)
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluent (VGS Fluent external support device)Device
Fluent external support device applied to saphenous vein graft
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Device applied to saphenous vein graft Receives: Device: Fluent (VGS Fluent external support device) |
| Control | No intervention | Saphenous vein graft without device support |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2013
- Study completionDec 2013
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 Heart 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
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT01415245
- Sponsor's protocol ID
- CI-01-01
- Acronym
- VEST
- Status last verified
- May 2014
- First submitted
- 10 Aug 2011
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Taggart DP, Webb CM, Desouza A, Yadav R, Channon KM, De Robertis F, Di Mario C. Long-term performance of an external stent for saphenous vein grafts: the VEST IV trial. J Cardiothorac Surg. 2018 Nov 19;13(1):117. doi: 10.1186/s13019-018-0803-9.
PubMed 30453984
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vein External Support Trial
- ClinicalTrials.gov ID
- NCT01415245
- Acronym / sponsor ID
- VEST / CI-01-01
- Conditions
- Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vascular Graft Solutions Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Aug 2011 (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.
Prospective, multi-center, randomized, controlled pilot study to demonstrate the safety and effectiveness of the VGS Fluent external support device, supporting saphenous vein grafts in patients with coronary heart disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Fluent (VGS Fluent external support device)Device applied to saphenous vein graft |
| Control | No intervention | –Saphenous vein graft without device support |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Fluent (VGS Fluent external support device)Fluent external support device applied to saphenous vein graft | Device | Treatment |
Primary outcome
Not reported in the source record.
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 20 May 2014.
- Derived from this study: PubMed 30453984Taggart DP, Webb CM, Desouza A, Yadav R, Channon KM, De Robertis F, Di Mario C. Long-term performance of an external stent for saphenous vein grafts: the VEST IV trial. J Cardiothorac Surg. 2018 Nov 19;13(1):117. doi: 10.1186/s13019-018-0803-9.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluent (VGS Fluent external support device) in people with Coronary Heart Disease, run by Vascular Graft Solutions Ltd. at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01415245, 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 20 May 2014.