Comparison of Two Different Endoscopic Radial Artery Harvesting Devices

Kerckhoff Klinik

Status: Completed

Conditions: CABG Graft Integrity

Treatments: Device: TLS2 endoscopic vessel harvesting; Device: LigaSure endoscopic vessel harvesting

Study type: Interventional

Funder types: Other

Identifiers

NCT03023475

VesselHarvestingLigaSure

Details and patient eligibility

About

Endoscopic radial artery harvesting in coronary bypass surgery is routinely performed by the investigators. In this study, the investigators want to compare the MiFusion TLS2 (Endotrust GmbH, Germany) device to the LigaSure Maryland Jaw (Medtronic, USA). The vessel harvesting is performed in the standard fashion according to the institutional routine. The patients are randomized preoperatively to one of the devices. The proximal end of the radial artery will be preserved and deep-frozen for histological assessment. Endothelial integrity will be investigated using Hematoxylin-Eosin, CD31 and endothelial nitrogen monoxide synthase.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all adult patients undergoing CABG using the radial artery
• capability to give informed consent

Exclusion criteria

• no specific exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

LigaSure endoscopic radial harvesting

Active Comparator group

Description:

The endoscopic vessel harvesting will be performed using the LigaSure device.

Treatment:

Device: LigaSure endoscopic vessel harvesting

TLS2 endoscopic radial harvesting

Active Comparator group

Description:

The endoscopic vessel harvesting will be performed using the TLS2 device.

Treatment:

Device: TLS2 endoscopic vessel harvesting