An interventional study of LigaSure endoscopic vessel harvesting and TLS2 endoscopic vessel harvesting in CABG Graft Integrity, sponsored by Kerckhoff Klinik. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-25.
Sponsored by Kerckhoff Klinik · Not applicable, Interventional, and Treatment
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.
Kerckhoff Klinik is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
The endoscopic vessel harvesting will be performed using the LigaSure device.
Device: LigaSure endoscopic vessel harvesting
The endoscopic vessel harvesting will be performed using the TLS2 device.
Device: TLS2 endoscopic vessel harvesting
The radial artery will be harvested endoscopically using the LigaSure system.
The radial artery will be harvested endoscopically using the TLS2 system.
Endothelial integrity of the radial artery using histological examination.
Time frame: Through study completion, an average of 1 year.
Harvesting time
Time frame: 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.
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.
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.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Kerckhoff Klinik