Ischemic Cardiovascular DiseaseRiVESTNCT06877195
Multicenter Randomised Prospective Study for External Support Mesh VEST of Venous Coronary Grafts on the Right Territory
A study testing CABG in people with Ischemic Cardiovascular Disease, run by Cardiochirurgia E.H. at 1 site in Italy.
Trial summary
Multicentre randomised prospective study aimed at verifying medium-term patency of venous grafts on the right coronary artery territory, by clinical and/or instrumental follow-up with particular attention to clinically driven re-revascularisation events regarding the site of new lesions (granularly comparing sites… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Cardiovascular Disease
- What is being tested?
- CABG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2025to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- combined or isolated interventions
- adequate vein calibre
- adequate graft flowmetry
Who cannot join
- inability to implant due to calibre disparity or inadequate flowmetry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Hospital
Roma, Roma, 00149
Luca Paolo Weltert, MD, +393478880617, lweltert@gmail.com
Luca Paolo Weltert, MD
About this study
Official title: Multicenter Randomised Prospective Study for External Support Mesh VEST of Venous Coronary Grafts on the Right Territory: Mid-term Clinically Driven Re-rivascularization Events Comparison Between Sites Treated With VEST, Sites Treated With Bare Vein, Sites Treated With Other Conduits and de Novo Lesions on the Native Vessels
Multicentre randomised prospective study aimed at verifying medium-term patency of venous grafts on the right coronary artery territory, by clinical and/or instrumental follow-up with particular attention to clinically driven re-revascularisation events regarding the site of new lesions (granularly comparing sites already treated with VEST, sites treated with bare vein, sites treated with other conduits, de novo lesions on the native).
- Conditions
- Ischemic Cardiovascular Disease
- Being tested
- CABG
- Keywords
- Coronary Artery Bypass Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABGProcedure or surgery
Aortocoronary bypass procedures with venous grafts on right coronary territory
| Study group | Role | What they receive |
|---|---|---|
| Vested vein | Experimental | Usage of External mesh support (VEST) around the venous graft Receives: Procedure: CABG |
| Unvested vein | Active comparator | Normally harvested and preserved "naked" vein used as a graft Receives: Procedure: CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ri-revascularization of grafted territory
Incidence of coronary ri-revascaularization by either angioplasty or surgical bypass concerning the grafted territory due to graft failure
Measured: Till end of study (at least three years)
Secondary outcomes (1)
Major Cardiovascular and Cerebrovascular Events (MACCE)
Incidence of Major Cardiovascular and Cerebrovascular Events
Measured: Till end of study (at least three years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Cardiovascular 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiochirurgia E.H.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Paolo Weltert, MD, Principal investigator, Unicamillus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877195
- Sponsor's protocol ID
- MCRiVEST-1
- Acronym
- RiVEST
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonimized clinical parameters
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomised Prospective Study for External Support Mesh VEST of Venous Coronary Grafts on the Right Territory: Mid-term Clinically Driven Re-rivascularization Events Comparison Between Sites Treated With VEST, Sites Treated With Bare Vein, Sites Treated With Other Conduits and de Novo Lesions on the Native Vessels
- ClinicalTrials.gov ID
- NCT06877195
- Acronym / sponsor ID
- RiVEST / MCRiVEST-1
- Conditions
- Ischemic Cardiovascular Disease
- Keywords
- Coronary Artery Bypass Graft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cardiochirurgia E.H.University, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 14 Mar 2025 (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.
Multicentre randomised prospective study aimed at verifying medium-term patency of venous grafts on the right coronary artery territory, by clinical and/or instrumental follow-up with particular attention to clinically driven re-revascularisation events regarding the site of new lesions (granularly comparing sites already treated with VEST, sites treated with bare vein, sites treated with other conduits, de novo lesions on the native).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vested vein | Experimental | Procedure: CABGUsage of External mesh support (VEST) around the venous graft |
| Unvested vein | Active comparator | Procedure: CABGNormally harvested and preserved "naked" vein used as a graft |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- combined or isolated interventions
- adequate vein calibre
- adequate graft flowmetry
Key exclusion criteria (1 listed)
- inability to implant due to calibre disparity or inadequate flowmetry
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 |
|---|---|---|
| CABGAortocoronary bypass procedures with venous grafts on right coronary territory | Procedure or surgery | Unvested vein, Vested vein |
Primary outcome
Ri-revascularization of grafted territory
Time frame: Till end of study (at least three years)
Incidence of coronary ri-revascaularization by either angioplasty or surgical bypass concerning the grafted territory due to graft failure
1 secondary outcome
Major Cardiovascular and Cerebrovascular Events (MACCE)
Time frame: Till end of study (at least three years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: Yes. Anonimized clinical parameters
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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.
Luca Paolo Weltert, MD principal investigator
Unicamillus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CABG in people with Ischemic Cardiovascular Disease, run by Cardiochirurgia E.H. at 1 site in Italy.
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 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: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca Paolo Weltert, MD (+393478880617, lweltert@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ri-revascularization of grafted territory (time frame: Till end of study (at least three years)). 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 18 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.