Comparison of Two Different Endoscopic Radial Artery Harvesting Devices

February 22, 2020 updated by: Kerckhoff Klinik

Prospective Randomized 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Nauheim, Germany, 61231
        • Kerckhoff Klinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • no specific exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: LigaSure endoscopic radial harvesting
The endoscopic vessel harvesting will be performed using the LigaSure device.
Device: LigaSure endoscopic vessel harvesting
The radial artery will be harvested endoscopically using the LigaSure system.
ACTIVE_COMPARATOR: TLS2 endoscopic radial 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 TLS2 system.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Harvesting time
Time Frame: The harvesting time will be measured during the vessel harvesting surgery.
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.
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.
The blood insufflation is performed immediately after vessel harvesting and leaks can be detected.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kerckhoff Klinik

Investigators

  • Principal Investigator: Arnaud Van Linden, MD, Kerckhoff Klinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2017

Primary Completion (ACTUAL)

September 30, 2017

Study Completion (ACTUAL)

February 28, 2018

Study Registration Dates

First Submitted

January 8, 2017

First Submitted That Met QC Criteria

January 13, 2017

First Posted (ESTIMATE)

January 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 22, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • VesselHarvestingLigaSure

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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