VEST Device to Enhance Safein Vein Patency

NCT06500897 | Completed

• 1 other identifier: EHMHVU-001
• Study Type: observational
• Target: 385
• Locations: 2 countries
• Sites: 3

Brief 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. 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

Keywords

Coronary Artery Bypass; Safein Vein; Mesh support

Outcome Measures

Primary Outcomes (2)

• Re-rivascularization

  Number of PCI or re-CABG performed, stratified by target site

  Up to 7 years

• MACCE

  Major adverse cardiac and cerebrovascular events

  Up to 7 years

Interventions

VEST DEVICE

External MEsh Support for safein vein

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All comers for CABG with at least one vessel treated with VESTed Vein

You may qualify if:

• CABG with at least one VEST implant

You may not qualify if:

• none

Sponsors & Collaborators

• Cardiochirurgia E.H.: lead

Study Sites (3)

Medical University of Vienna

Vienna, Austria

Location

Cardiochirurgia European Hospital

Rome, 00152, Italy

Location

Mauriziano Hospital

Turin, Italy

Location

Related Publications (3)

• 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.

  PMID: 30767438 BACKGROUND

• Weltert 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.

  PMID: 33845865 RESULT

• Sandner 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.

  PMID: 35312782 RESULT

Study Officials

• Luca We

  European Hospital - Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: January 2, 2017
• Primary Completion: June 30, 2024
• Study Completion: July 8, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); IT (2)