Comparison of Two Different Endoscopic Radial Artery Harvesting Devices

Not Applicable

Completed

• Conditions: CABG Graft Integrity
• Interventions: Device: LigaSure endoscopic vessel harvesting; Device: TLS2 endoscopic vessel harvesting

• Registration Number: NCT03023475
• Lead Sponsor: Kerckhoff Klinik

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-08
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-18
• Study Start: 2017-02-01
• Primary Completion: 2017-09-30
• Study Completion: 2018-02-28
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-22
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• no specific exclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LigaSure endoscopic radial harvesting	LigaSure endoscopic vessel harvesting	The endoscopic vessel harvesting will be performed using the LigaSure device.
TLS2 endoscopic radial harvesting	TLS2 endoscopic vessel harvesting	The endoscopic vessel harvesting will be performed using the TLS2 device.

Primary Outcome Measures

Name	Time	Method
Endothelial integrity of the radial artery using histological examination.	Through study completion, an average of 1 year.

Secondary Outcome Measures

Name	Time	Method
Hemostasis in the arm indicated by bleeding from radial artery side branches or veins in the arm.	Intraoperatively and directly after vessel harvesting the arm is controlled using the endoscope and bleeding can be detected during this control. End of surgery is end of this outcome parameter.
Accuracy of vessel sealing, if side branches of the radial artery are bleeding after blood insufflation, additional clips have to placed at the side branch.	The blood insufflation is performed immediately after vessel harvesting and leaks can be detected.
Harvesting time	The harvesting time will be measured during the vessel harvesting surgery.

Trial Locations

Locations (1)

Kerckhoff Klinik; 🇩🇪 Bad Nauheim, Germany