CABG Graft IntegrityNCT03023475
Comparison of Two Different Endoscopic Radial Artery Harvesting Devices
A study testing LigaSure endoscopic vessel harvesting and TLS2 endoscopic vessel harvesting in people with CABG Graft Integrity, run by Kerckhoff Klinik at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CABG Graft Integrity
- What is being tested?
- LigaSure endoscopic vessel harvesting and TLS2 endoscopic vessel harvesting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2017to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all adult patients undergoing CABG using the radial artery
- capability to give informed consent
Who cannot join
- no specific exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- CABG Graft Integrity
- Being tested
- LigaSure endoscopic vessel harvesting, TLS2 endoscopic vessel harvesting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LigaSure endoscopic vessel harvestingDevice
The radial artery will be harvested endoscopically using the LigaSure system.
TLS2 endoscopic vessel harvestingDevice
The radial artery will be harvested endoscopically using the TLS2 system.
| Study group | Role | What they receive |
|---|---|---|
| LigaSure endoscopic radial harvesting | Active comparator | The endoscopic vessel harvesting will be performed using the LigaSure device. Receives: Device: LigaSure endoscopic vessel harvesting |
| TLS2 endoscopic radial harvesting | Active comparator | The endoscopic vessel harvesting will be performed using the TLS2 device. Receives: Device: TLS2 endoscopic vessel harvesting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial integrity of the radial artery using histological examination.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (3)
Harvesting time
Measured: 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.
Measured: 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.
Measured: The blood insufflation is performed immediately after vessel harvesting and leaks can be detected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion30 Sep 2017
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CABG Graft IntegrityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerckhoff Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Van Linden, MD, Principal investigator, Kerckhoff Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023475
- Sponsor's protocol ID
- VesselHarvestingLigaSure
- Status last verified
- Feb 2020
- First submitted
- 8 Jan 2017
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Two Different Endoscopic Radial Artery Harvesting Devices
- ClinicalTrials.gov ID
- NCT03023475
- Acronym / sponsor ID
- VesselHarvestingLigaSure
- Conditions
- CABG Graft Integrity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kerckhoff KlinikUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LigaSure endoscopic radial harvesting | Active comparator | Device: LigaSure endoscopic vessel harvestingThe endoscopic vessel harvesting will be performed using the LigaSure device. |
| TLS2 endoscopic radial harvesting | Active comparator | Device: TLS2 endoscopic vessel harvestingThe endoscopic vessel harvesting will be performed using the TLS2 device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all adult patients undergoing CABG using the radial artery
- capability to give informed consent
Key exclusion criteria (1 listed)
- no specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LigaSure endoscopic vessel harvestingThe radial artery will be harvested endoscopically using the LigaSure system. | Device | LigaSure endoscopic radial harvesting |
| TLS2 endoscopic vessel harvestingThe radial artery will be harvested endoscopically using the TLS2 system. | Device | TLS2 endoscopic radial harvesting |
Primary outcome
Endothelial integrity of the radial artery using histological examination.
Time frame: Through study completion, an average of 1 year.
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Individual participant dataSharing planned: No
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Recruiting
The Relationship Between Blood Flow Readings During Surgery and How Well the Graft Stays Open and How Patients Recover Afterward in Coronary Artery Bypass Graft Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud Van Linden, MD principal investigator
Kerckhoff Klinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LigaSure endoscopic vessel harvesting and TLS2 endoscopic vessel harvesting in people with CABG Graft Integrity, run by Kerckhoff Klinik at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial integrity of the radial artery using histological examination. (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.