Coronary Artery Bypass SurgeryVEST IINCT02332330
CD0104 VEST II Post Marketing Surveillance Study
A study testing VEST in people with Coronary Artery Bypass Surgery, run by Vascular Graft Solutions Ltd. at 2 sites in 2 countries.
Trial summary
This study is designed to collect post market data on use of the VEST, particularly on saphenous vein grafts to the right territory of the heart. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Bypass Surgery
- What is being tested?
- VEST
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2015to Apr 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient scheduled for on-pump CABG on clinical grounds
- At least one vein graft bypass indicated for right coronary artery and LIMA 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, as assessed from the pre-operative cardiac angiography.
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 and before VEST implantation.
- Prior debilitating stroke less than 1 year before surgery
- Severe renal dysfunction (Cr>2.0 mg/dL)
- Concomitant life-threatening disease likely to limit life expectancy to less than 2 years.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Post-market Prospective Study of the VGS VEST (Venous External Support), Supporting Saphenous Vein Grafts for Coronary Bypass Graft Surgery in Patients With Severe Coronary Heart Disease
This study is designed to collect post market data on use of the VEST, particularly on saphenous vein grafts to the right territory of the heart.
Read the detailed description
The primary objective is to test the early-mid term patency rate of VEST supported Right Coronary Artery (RCA) bypass grafts. The research participants will undergo CABG preparations and CABG procedure routinely as is the standard of care. During the procedure the VEST will be implanted on the vein graft to the Right Coronary Artery according to the IFU. Perioperative care is according to standard of care. Upon discharge patient will be prescribed statins and aspirin for 6 months. Patient will attend a routine clinic visit 4-6 weeks post operatively. The last study visit will occur 3-6 months post operatively. Patients will undergo a noninvasive coronary CT angiography.
- Conditions
- Coronary Artery Bypass Surgery
- Being tested
- VEST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VESTDevice
| Study group | Role | What they receive |
|---|---|---|
| VEST | Experimental | Not described Receives: Device: VEST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vein graft patency by CT angiography
Measured: 3-6 monthws
MACCE
Major adverse cardiac and cerebral events
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass SurgeryStudies 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
- Not applicable
- Intervention model
- Single group
- 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
- Investigators
- David P Taggart, Professor, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332330
- Sponsor's protocol ID
- CD0104
- Acronym
- VEST II
- Status last verified
- Oct 2015
- First submitted
- 4 Jan 2015
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Prospective Study of the VGS VEST (Venous External Support), Supporting Saphenous Vein Grafts for Coronary Bypass Graft Surgery in Patients With Severe Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT02332330
- Acronym / sponsor ID
- VEST II / CD0104
- Conditions
- Coronary Artery Bypass Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vascular Graft Solutions Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 6 Jan 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.
This study is designed to collect post market data on use of the VEST, particularly on saphenous vein grafts to the right territory of the heart.
Detailed description
The primary objective is to test the early-mid term patency rate of VEST supported Right Coronary Artery (RCA) bypass grafts. The research participants will undergo CABG preparations and CABG procedure routinely as is the standard of care. During the procedure the VEST will be implanted on the vein graft to the Right Coronary Artery according to the IFU. Perioperative care is according to standard of care. Upon discharge patient will be prescribed statins and aspirin for 6 months. Patient will attend a routine clinic visit 4-6 weeks post operatively. The last study visit will occur 3-6 months post operatively. Patients will undergo a noninvasive coronary CT angiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VEST | Experimental | Device: VEST |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient scheduled for on-pump CABG on clinical grounds
- At least one vein graft bypass indicated for right coronary artery and LIMA 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, as assessed from the pre-operative cardiac angiography.
Key exclusion criteria (8 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 and before VEST implantation.
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 | Device | VEST |
Primary outcome
Vein graft patency by CT angiography
Time frame: 3-6 monthws
MACCE
Time frame: 3-6 months
Major adverse cardiac and cerebral events
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 28 Apr 2016.
Related trials for Coronary Artery Bypass Surgery
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Recruiting
CCTA-Based vs CAG-Based CABG: A Multicenter Pragmatic Non-Inferiority Trial
Coronary Artery Disease, Coronary Artery Bypass Grafting
Recruiting
Fasciotomy and Predilation for Radial Artery Grafts in CABG
Coronary Artery Bypass, Radial Artery Grafts
RecruitingPhase 3
Comparing High and lOw-dose asPirin With Dual anTIplatelet Therapy for Three Months Using prasUgrel and aSpirin Following Coronary Artery Bypass Grafting. (OPTIMUS-CABG Trial)
Chronic Coronary Syndrome, Stable Coronary Artery Disease CAD
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
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.
David P Taggart, Professor principal investigator
Oxford University Hospitals NHS Trust
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VEST in people with Coronary Artery Bypass Surgery, run by Vascular Graft Solutions Ltd. at 2 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 3 inclusion and 8 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 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, 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.
What does the primary outcome measure?
Vein graft patency by CT angiography (time frame: 3-6 monthws). The study lists 2 primary outcomes in all. 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 28 Apr 2016.