Comparison of Two Different Endoscopic Radial Artery Harvesting Devices

Prospective Randomized Comparison of Two Different Endoscopic Radial Artery Harvesting Devices

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03023475

Enrollment

100

Registered

2017-01-18

Start date

2017-02-01

Completion date

2018-02-28

Last updated

2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CABG Graft Integrity

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.

Interventions

DEVICELigaSure endoscopic vessel harvesting

The radial artery will be harvested endoscopically using the LigaSure system.

DEVICETLS2 endoscopic vessel harvesting

The radial artery will be harvested endoscopically using the TLS2 system.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* no specific

Design outcomes

Primary

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

Secondary

Measure	Time frame
Harvesting time	The harvesting time will be measured during the vessel harvesting surgery.
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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026