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Preparation of Internal Thoracic ArteryNCT03510026

Low Thermal Electrosurgical Device for Atraumatic Internal Thoracic Artery Harvesting

A study testing Low thermal device preparation in people with Preparation of Internal Thoracic Artery, run by Triemli Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Electrosurgery is fundamental to the precise, fast and bloodless preparation of internal thoracic artery grafts in cardiac surgery. The PEAK PlasmaBlade is a monopolar electrosurgical device that uses pulsed radiofrequency energy to generate a plasma-mediated discharge along an insulated electrode, creating a cutting… Read more about this study

Who is it for?
Any age
Conditions the study is for
Preparation of Internal Thoracic Artery
What is being tested?
Low thermal device preparation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
8 Aug 2013to 1 Oct 2014
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • all patients receiving elective coronary artery bypass grafting with both internal thoracic arteries
  • signed consent

Who cannot join

  • emergency procedures
  • patients, who are already involved in other studies
  • pregnant women or women of childbearing Age
  • missing signed consent

About this study

Official title: Skeletonized Internal Thoracic Artery Harvesting: A Low Thermal Electrosurgical Device Provides Improved Endothelial Layer and Better Integrity of the Vessel Wall

Electrosurgery is fundamental to the precise, fast and bloodless preparation of internal thoracic artery grafts in cardiac surgery. The PEAK PlasmaBlade is a monopolar electrosurgical device that uses pulsed radiofrequency energy to generate a plasma-mediated discharge along an insulated electrode, creating a cutting edge while the blade stays near body temperature. The aim of this study is to compare the histological samples, cardiac computed-tomography of graft patency, and clinical outcomes of patients after off-pump coronary artery bypass grafting with preparation of the internal thoracic arteries by a conventional electrosurgical device and the PlasmaBlade.

Read the detailed description

Electrosurgery is fundamental to the precise, fast and bloodless preparation of internal thoracic artery grafts in cardiac surgery. The fundamental performance of electrosurgical dissection is created by using a continuous radiofrequency energy waveform, which thermally ablates soft tissue, leaving a collateral damage zone of 100-400 µm. The basic mechanism of tissue ablation and dissection in electrosurgery involves Joule heating of the conductive tissue by electric current, that leads to vaporization and ionization of the water content in the tissue adjacent to the electrode, and ultimately to vapor expansion and tissue fragmentation. Tissue heated below the vaporization threshold remains in place, but can undergo thermal denaturation determined by the temperature levels and duration of the hyperthermia. Thus, to confine the collateral damage zone in tissue, both of these factors should be minimized.

In contrast to continuous radiofrequency energy, pulsed electric waveforms with burst durations ranging from 10 to 100 µsec applied via an insulated planar electrode with 12 µm wide exposed edge produces a plasma-mediated, precise dissection of tissues with a lower collateral damage zone ranging from 2 to 10 µm. The greatly reduced zone of thermal damage, compared to conventional electrosurgical devices, may provide faster healing and less scarring.

The PEAK PlasmaBlade (Medtronic Advanced Energy, Portsmouth, NH USA) (FDA 510(k), CE-No. 540861, Model Number PS200-040) is an electrosurgical device that uses pulsed radiofrequency energy to generate a plasma-mediated discharge along the exposed rim of an insulated blade, creating an effective, precise cutting edge while the blade stays near body temperature. Plasma is an electrically conductive cloud created when the energy contacts tissue. This conductive cloud or "plasma" allows the radiofrequency energy to cross at much lower overall power levels. This use of less energy via plasma results in lower operating temperatures and less thermal damage. This technology has been shown to effectively dissect ophthalmologic and cutaneous tissues as precisely as a scalpel with the hemostatic control of conventional electrosurgery in clinical and experimental settings.

Concentrating on bypass grafts, the thoracic internal arteries (ITAs) demonstrate our most valuable conduit for revascularization of the coronary arteries. Compared to pedicled arteries, skeletonized ITAs have demonstrated a tendency to better long term patency. Additionally, skeletonized conduits are useful in expanding the number of anastomoses per patient and reducing the incidence of sternal complications.

The use of a dissection device that provides precise preparation, including optimal bleeding control without overly damaging the surrounding tissue, might be an optimizing factor for the protection of these valuable bypass grafts. The aim of this study was to compare the histological assessment, cardiac computed-tomography and clinical outcomes of patients following off-pump coronary artery bypass grafting with preparation of the ITAs by conventional electrosurgery and the PlasmaBlade.

Being tested
Low thermal device preparation
Keywords
internal thoracic artery harvesting, arterial graft patency, electrosurgery, arterial graft preparation
Medical subject headings
Hyperthermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low thermal device preparationDevice

    One participant acts simultaneously as a control and active comparator. One internal thoracic artery is prepared with the normal electrocautery device. The other internal thoracic artery is prepared with the new low thermal device. The participant does not know, which internal thoracic artery is defined to be prepared with the low thermal device.

Study groups in NCT03510026
Study groupRoleWhat they receive
Low thermal device preparationOtherOne participant acts simultaneously as a control and active comparator. One internal thoracic artery is prepared with the normal electrocautery device. The other internal thoracic artery is prepared with the new low thermal device. The participant does not know, which internal thoracic artery is defined to be prepared with the low thermal device.
Receives: Device: Low thermal device preparation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endothelial damage

    Histological examination of internal thoracic artery samples stained for endothelial damage.

    Measured: six months

Secondary outcomes (2)
  1. Vessel wall integrity

    Histological examination of internal thoracic artery samples stained for vessel wall integrity.

    Measured: six months

  2. Patency of internal thoracic arteries as bypass grafts

    Computed tomography six months after bypass operation

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2018
  2. Study start8 Aug 2013
  3. Primary completion1 Apr 2014
  4. Study completion1 Oct 2014

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03510026
Sponsor's protocol ID
KEK-ZH-Nr. 2013-0017
Status last verified
Apr 2018
First submitted
4 Apr 2018
Last updated
27 Apr 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zientara A, Komminoth P, Seifert B, Odavic D, Dzemali O, Haussler A, Genoni M. Skeletonized internal thoracic artery harvesting: a low thermal damage electrosurgical device provides improved endothelial layer and tendency to better integrity of the vessel wall compared to conventional electrosurgery. J Cardiothorac Surg. 2018 Oct 11;13(1):105. doi: 10.1186/s13019-018-0797-3.

    PubMed 30305183

Questions about this trial

What is this clinical trial studying?

A study testing Low thermal device preparation in people with Preparation of Internal Thoracic Artery, run by Triemli Hospital.

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 4 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 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

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 damage (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03510026, which also lists 1 linked publication.

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 27 Apr 2018.

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