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OpenTrials
Completed

NCT Number: NCT03023475

Comparison of Two Different Endoscopic Radial Artery Harvesting Devices

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.

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Key information

Conditions

CABG Graft Integrity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kerckhoff Klinik

Bad Nauheim, 61231, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • no specific exclusion criteria

Treatment and study plan

LigaSure endoscopic vessel harvesting

Device

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

TLS2 endoscopic vessel harvesting

Device

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

Primary outcomes

  1. Endothelial integrity of the radial artery using histological examination.

    Time frame: Through study completion, an average of 1 year.

Secondary outcomes

  1. Harvesting time

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

  2. Hemostasis in the arm indicated by bleeding from radial artery side branches or veins in the arm.

    Time frame: 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.

  3. 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.

    Time frame: The blood insufflation is performed immediately after vessel harvesting and leaks can be detected.

Sponsors and collaborators

Lead sponsor

Kerckhoff Klinik

Other

Registry information

Official study title

Prospective Randomized Comparison of Two Different Endoscopic Radial Artery Harvesting Devices

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jan 18, 2017
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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