Evaluating outcomes of CABG surgery with VEST supported venous grafts
Clinical Outcomes of Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery With VEST Supported Venous Grafts
This study is testing whether using a special support device called VEST on vein grafts during heart bypass surgery can improve the health and quality of life for patients with coronary artery disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cardiocentro Ticino Academic / other |
| Locations | 13 sites (Innsbruck and 12 other locations) |
| Trial ID | NCT04761068 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to assess the clinical outcomes of patients undergoing coronary artery bypass grafting (CABG) surgery who will receive an external support device known as VEST for their saphenous vein grafts (SVG). The study will enroll patients with atherosclerotic coronary artery disease scheduled for CABG with at least one SVG bypass. Participants will be followed for five years, with interim assessments at 12 and 24 months to document major adverse cardiac and cerebrovascular events (MACCE) and quality of life measures using the EQ5D3L scale. The use of the VEST device will be guided by clinical judgment and its approved indications.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years scheduled for planned CABG with at least one SVG bypass and pre-planned VEST treatment.
Not a fit: Patients undergoing emergency CABG surgery or those participating in other investigational studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the long-term outcomes of CABG surgery by enhancing the performance of venous grafts.
How similar studies have performed: While the use of external support devices in CABG is a novel approach, similar studies have shown promising results in improving graft outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient scheduled for planned CABG procedure with at least one SVG bypass with pre-planned VEST treatment. 2. Saphenous vein graft length and diameter are adequate for the planned intervention. 3. Patient is willing and able to give their written informed consent to participate in the registry study. 4. Patient is over 18 years of age Exclusion Criteria: 1. Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP) 2. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
Where this trial is running
Innsbruck and 12 other locations
- Medical University of Innsbruck — Innsbruck, Austria (Recruiting)
- AKH (Vienna General Hospital) — Vienna, Austria (Recruiting)
- Floridsdorf Clinic — Vienna, Austria (Recruiting)
- Herzzentrum Dresden — Dresden, Germany (Terminated)
- Klinikum Nürnberg — Nürnberg, Germany (Recruiting)
- Krankenhaus der Barmherzigen Brüder — Trier, Germany (Recruiting)
- European hospital — Roma, Italy (Recruiting)
- Mauriziano Hospital — Turin, Italy (Recruiting)
- Germans Trias i Pujol — Badalona, Spain (Recruiting)
- University hospital of the Canary Islands — Santa Cruz De Tenerife, Spain (Recruiting)
- Ribera hospital — Valencia, Spain (Recruiting)
- Cardiocentro Ticino — Lugano, Switzerland (Recruiting)
- Triemli University Hospital — Zürich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Stefanos Demertzis — Cardiocentro Ticino
- Study coordinator: Stefanos Demertzis, Professor
- Email: Stefanos.Demertzis@cardiocentro.org
- Phone: +41918053147
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.