Prospective Randomized Comparison of Two Different Endoscopic Radial Artery Harvesting Devices
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- CABG Graft Integrity
- Sponsor
- Kerckhoff Klinik
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Endothelial integrity of the radial artery using histological examination.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •all adult patients undergoing CABG using the radial artery
- •capability to give informed consent
Exclusion Criteria
- •no specific exclusion criteria
Outcomes
Primary Outcomes
Endothelial integrity of the radial artery using histological examination.
Time Frame: Through study completion, an average of 1 year.
Secondary Outcomes
- 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.)