VEST Device to Enhance Safein Vein Patency

NCT ID: NCT06500897

Last Updated: 2024-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

385 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-02

Study Completion Date

2024-07-08

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Bypass

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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VEST

External MEsh Support for safein vein

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* CABG with at least one VEST implant

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiochirurgia E.H.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luca We

Role: PRINCIPAL_INVESTIGATOR

European Hospital - Rome

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Cardiochirurgia European Hospital

Rome, , Italy

Site Status

Mauriziano Hospital

Turin, , Italy

Site Status

Countries

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Austria Italy

References

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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.

Reference Type BACKGROUND
PMID: 30767438 (View on PubMed)

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.

Reference Type RESULT
PMID: 33845865 (View on PubMed)

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.

Reference Type RESULT
PMID: 35312782 (View on PubMed)

Other Identifiers

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EHMHVU-001

Identifier Type: -

Identifier Source: org_study_id

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