Clinical trial NCT06500897: VEST Device to Enhance Safein Vein Patency
Official title: Mid Term Follow up of VEST Device to Enhance Safein Vein Patency: a Multicentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Bypass
Keywords: Coronary Artery Bypass
Safein Vein
Mesh support
Lead sponsor: Cardiochirurgia E.H.
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 385
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All comers for CABG with at least one vessel treated with VESTed Vein

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.


Eligibility criteria: Inclusion Criteria:

* CABG with at least one VEST implant

Exclusion Criteria:

* none

Primary outcomes:
measure: Re-rivascularization
timeFrame: Up to 7 years
measure: MACCE
timeFrame: Up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Rome
country: Italy
facility: Cardiochirurgia European Hospital
city: Turin
country: Italy
facility: Mauriziano Hospital
Study officials:
affiliation: European Hospital - Rome
name: Luca We
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.