Evaluating a new mesh for supporting venous grafts in heart surgery
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
This study is testing a new mesh to see if it can help improve the success of heart surgery by supporting grafts used in bypass procedures for people with heart problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Cardiochirurgia E.H. Academic / other |
| Locations | 1 site (Roma, Roma) |
| Trial ID | NCT06877195 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized prospective study aims to assess the medium-term effectiveness of a new external support mesh, VEST, for venous coronary grafts specifically in the right coronary artery territory. The study will involve clinical and instrumental follow-ups to monitor the patency of these grafts and will compare outcomes between grafts treated with VEST, bare veins, and other conduits. The focus will be on clinically driven re-revascularization events and the emergence of new lesions. This approach seeks to improve the success rates of coronary artery bypass grafting (CABG) procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are patients undergoing coronary artery bypass grafting with suitable vein caliber and graft flowmetry.
Not a fit: Patients who cannot undergo grafting due to inadequate vein caliber or flowmetry will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the long-term success of coronary artery bypass grafts, leading to better patient outcomes.
How similar studies have performed: While similar studies have explored graft support techniques, the specific use of the VEST mesh in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * combined or isolated interventions * adequate vein calibre * adequate graft flowmetry Exclusion Criteria: * inability to implant due to calibre disparity or inadequate flowmetry
Where this trial is running
Roma, Roma
- European Hospital — Roma, Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Luca Paolo Weltert, MD — Unicamillus
- Study coordinator: Luca Paolo Weltert, MD
- Email: lweltert@gmail.com
- Phone: +393478880617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.