Coronary Artery BypassNCT06500897
VEST Device to Enhance Safein Vein Patency
An observational study of Coronary Artery Bypass, run by Cardiochirurgia E.H. at 3 sites in 2 countries.
Trial summary
Purpose - Bypass grafting is the gold standard for severe coronary disease, yet most repeat revascularizations target previously grafted territories. External stenting of saphenous vein grafts, the most frequently used bypass conduit, has been shown to minimize disease markers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Bypass
- What is being tested?
- VEST
- Type of treatment
- Medical device
- How many people
- 385 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 2 Jan 2017to 8 Jul 2024
- Phase
- Observational
- 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
Study population: All comers for CABG with at least one vessel treated with VESTed Vein
Who may be able to join
- CABG with at least one VEST implant
Who cannot join
- none
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Italy2 sites
Cardiochirurgia European Hospital
Rome, 00152
Mauriziano Hospital
Turin
About this study
Official title: Mid Term Follow up of VEST Device to Enhance Safein Vein Patency: a Multicentric Study
Purpose - Bypass grafting is the gold standard for severe coronary disease, yet most repeat revascularizations target previously grafted territories. External stenting of saphenous vein grafts, the most frequently used bypass conduit, has been shown to minimize disease markers. This study evaluates clinical outcomes of external stenting in real world routine practice.
Methods - Three centers enrolled a prospective real-world cohort of external- stenting- enhanced CABG patients. All patients received an internal mammary artery graft to the left anterior descending artery and additional arterial and/or venous grafts. One or more venous grafts were externally stented. Choice of conduits, use of cardiopulmonary bypass, and vein harvesting technique were performed according to the routine practice of each surgeon.
All patients were prescribed standard of care medication and were followed via on site visits or phone interviews for major adverse myocardial and cerebral effects.
- Conditions
- Coronary Artery Bypass
- Being tested
- VEST
- Keywords
- Coronary Artery Bypass, Safein Vein, Mesh support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VESTDevice
External MEsh Support for safein vein
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-rivascularization
Number of PCI or re-CABG performed, stratified by target site
Measured: Up to 7 years
MACCE
Major adverse cardiac and cerebrovascular events
Measured: Up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start2 Jan 2017
- Primary completion30 Jun 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery BypassStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiochirurgia E.H.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca We, Principal investigator, European Hospital - Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500897
- Sponsor's protocol ID
- EHMHVU-001
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sandner S, Angleitner P, Laufer G, Zimpfer D. External stent (VEST) for saphenous vein grafts in coronary artery bypass grafting. Multimed Man Cardiothorac Surg. 2019 Feb 1;2019. doi: 10.1510/mmcts.2019.007.
PubMed 30767438Weltert LP, Audisio K, Bellisaro A, Bardi G, Flocco R, De Paulis R, Centofanti P. External stenting of vein grafts in coronary artery bypass grating: interim results from a two centers prospective study. J Cardiothorac Surg. 2021 Apr 12;16(1):74. doi: 10.1186/s13019-021-01406-0.
PubMed 33845865Sandner SE, Donovan TJ, Edelstein S, Puskas JD, Angleitner P, Krasopoulos G, Channon K, Gehrig T, Rajakaruna C, Ladyshenskij L, De Silva R, Bonaros N, Bolotin G, Jacobs S, Thielmann M, Choi YH, Ohri S, Lipey A, Friedrich I, Taggart DP. Effects of the harvesting technique and external stenting on progression of vein graft disease 2 years after coronary artery bypass. Eur J Cardiothorac Surg. 2022 Jun 15;62(1):ezac045. doi: 10.1093/ejcts/ezac045.
PubMed 35312782
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid Term Follow up of VEST Device to Enhance Safein Vein Patency: a Multicentric Study
- ClinicalTrials.gov ID
- NCT06500897
- Acronym / sponsor ID
- EHMHVU-001
- Conditions
- Coronary Artery Bypass
- Keywords
- Coronary Artery Bypass, Safein Vein, Mesh support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Cardiochirurgia E.H.University, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 15 Jul 2024 (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.
Purpose - Bypass grafting is the gold standard for severe coronary disease, yet most repeat revascularizations target previously grafted territories. External stenting of saphenous vein grafts, the most frequently used bypass conduit, has been shown to minimize disease markers. This study evaluates clinical outcomes of external stenting in real world routine practice.
Methods - Three centers enrolled a prospective real-world cohort of external- stenting- enhanced CABG patients. All patients received an internal mammary artery graft to the left anterior descending artery and additional arterial and/or venous grafts. One or more venous grafts were externally stented. Choice of conduits, use of cardiopulmonary bypass, and vein harvesting technique were performed according to the routine practice of each surgeon.
All patients were prescribed standard of care medication and were followed via on site visits or phone interviews for major adverse myocardial and cerebral effects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All comers for CABG with at least one vessel treated with VESTed Vein
Key inclusion criteria (1 listed)
- CABG with at least one VEST implant
Key exclusion criteria (1 listed)
- none
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 MEsh Support for safein vein | Device | – |
Primary outcome
Re-rivascularization
Time frame: Up to 7 years
Number of PCI or re-CABG performed, stratified by target site
MACCE
Time frame: Up to 7 years
Major adverse cardiac and cerebrovascular 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 16 Jul 2024.
- Background: PubMed 30767438Sandner S, Angleitner P, Laufer G, Zimpfer D. External stent (VEST) for saphenous vein grafts in coronary artery bypass grafting. Multimed Man Cardiothorac Surg. 2019 Feb 1;2019. doi: 10.1510/mmcts.2019.007.
- Results publication: PubMed 33845865Weltert LP, Audisio K, Bellisaro A, Bardi G, Flocco R, De Paulis R, Centofanti P. External stenting of vein grafts in coronary artery bypass grating: interim results from a two centers prospective study. J Cardiothorac Surg. 2021 Apr 12;16(1):74. doi: 10.1186/s13019-021-01406-0.
- Results publication: PubMed 35312782Sandner SE, Donovan TJ, Edelstein S, Puskas JD, Angleitner P, Krasopoulos G, Channon K, Gehrig T, Rajakaruna C, Ladyshenskij L, De Silva R, Bonaros N, Bolotin G, Jacobs S, Thielmann M, Choi YH, Ohri S, Lipey A, Friedrich I, Taggart DP. Effects of the harvesting technique and external stenting on progression of vein graft disease 2 years after coronary artery bypass. Eur J Cardiothorac Surg. 2022 Jun 15;62(1):ezac045. doi: 10.1093/ejcts/ezac045.
- Individual participant dataSharing planned: No
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Coronary Artery Bypass Graft (CABG)
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.
Luca We principal investigator
European Hospital - Rome
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Bypass, run by Cardiochirurgia E.H. at 3 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 1 inclusion and 1 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 16 Jul 2024. 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 Italy, Austria. 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?
Re-rivascularization (time frame: Up to 7 years). 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?
On the ClinicalTrials.gov record for NCT06500897, which also lists 3 linked publications.
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 16 Jul 2024.