Comparison of Two Different Endoscopic Radial Artery Harvesting Devices

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Comparison of Two Different Endoscopic Radial Artery Harvesting Devices

Conditions
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CABG Graft Integrity

Intervention / Treatment
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* Device: LigaSure endoscopic vessel harvesting
* Device: TLS2 endoscopic vessel harvesting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all adult patients undergoing CABG using the radial artery capability to give informed consent Exclusion Criteria: no specific exclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LigaSure endoscopic radial harvesting<br>The endoscopic vessel harvesting will be performed using the LigaSure device. | Device: LigaSure endoscopic vessel harvesting<br>* The radial artery will be harvested endoscopically using the LigaSure system.<br>|
| Active Comparator: TLS2 endoscopic radial harvesting<br>The endoscopic vessel harvesting will be performed using the TLS2 device. | Device: TLS2 endoscopic vessel harvesting<br>* The radial artery will be harvested endoscopically using the TLS2 system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial integrity of the radial artery using histological examination. |  | Through study completion, an average of 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |