Meshed Vein Graft Patency Trial - VEST
Sponsor
Cardiochirurgia E.H. (Other)
Overall Status
Completed
CT.gov ID
NCT01860274
Collaborator
(none)
102
2
1
57.7
51
0.9
Study Details
Study Description
Brief Summary
The study hypothesis is that a meshed conduit made of safen vein allows a better patency at mid-long term than a safen vein alone.
To test this hypothesis the investigators plan a prospective, randomized study, comparing grafts to the diagonal, in cases of vessel diameter under 1.5mm. A control angiography will be performed one year after the operation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
102 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
External Mesh of Vein Grafts In Coronary Artery Bypass Grating: Early Patency and Clinical Outcome
Actual Study Start Date
:
Sep 6, 2015
Actual Primary Completion Date
:
Dec 31, 2019
Actual Study Completion Date
:
Jun 28, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: External Mesh
|
Device: External Mesh for vein grafts
|
Outcome Measures
Primary Outcome Measures
- Patency [6 to 12 months]
Patency of graft at CT Scan
Secondary Outcome Measures
- Major Adverse Cardiac and Cerebrovascular Events (MACCE) [60 months]
- Vein graft lumen uniformity [6 to 12 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Clinical Indication for elective Coronary Artery Bypass Grafting with at least one vein graft
-
Coronary artery with critical stenosis (over 70%)
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | European Hospital | Rome | Italy | 00149 | |
| 2 | Mauriziano Hospital | Turin | Italy |
Sponsors and Collaborators
- Cardiochirurgia E.H.
Investigators
- Principal Investigator: Luca Weltert, MD, European Hospital - Rome
- Study Chair: Ruggero De Paulis, MD, European Hospital - Rome
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Cardiochirurgia E.H.
ClinicalTrials.gov Identifier:
NCT01860274
Other Study ID Numbers:
- 00-06
First Posted:
May 22, 2013
Last Update Posted:
Mar 12, 2021
Last Verified:
Mar 1, 2021
Keywords provided by Cardiochirurgia E.H.
Additional relevant MeSH terms: