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.
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.
- Conditions
- Preparation of Internal Thoracic Artery
- 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 group | Role | What they receive |
|---|---|---|
| Low thermal device preparation | Other | 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. Receives: Device: Low thermal device preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial damage
Histological examination of internal thoracic artery samples stained for endothelial damage.
Measured: six months
Secondary outcomes (2)
Vessel wall integrity
Histological examination of internal thoracic artery samples stained for vessel wall integrity.
Measured: six months
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.
- First posted27 Apr 2018
- Study start8 Aug 2013
- Primary completion1 Apr 2014
- Study completion1 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preparation of Internal Thoracic ArteryStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Triemli Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alicja Zientara, Triemli Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletonized Internal Thoracic Artery Harvesting: A Low Thermal Electrosurgical Device Provides Improved Endothelial Layer and Better Integrity of the Vessel Wall
- ClinicalTrials.gov ID
- NCT03510026
- Acronym / sponsor ID
- KEK-ZH-Nr. 2013-0017
- Conditions
- Preparation of Internal Thoracic Artery
- Keywords
- internal thoracic artery harvesting, arterial graft patency, electrosurgery, arterial graft preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Triemli HospitalUniversity, hospital or other
- Study start
- 8 Aug 2013 (actual)
- Primary completion
- 1 Apr 2014 (actual)
- Study completion
- 1 Oct 2014 (actual)
- First posted
- 27 Apr 2018 (actual)
- 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low thermal device preparation | Other | Device: Low thermal device preparationOne 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- all patients receiving elective coronary artery bypass grafting with both internal thoracic arteries
- signed consent
Key exclusion criteria (4 listed)
- emergency procedures
- patients, who are already involved in other studies
- pregnant women or women of childbearing Age
- missing signed consent
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 |
|---|---|---|
| Low thermal device preparationOne 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. | Device | Low thermal device preparation |
Primary outcome
Endothelial damage
Time frame: six months
Histological examination of internal thoracic artery samples stained for endothelial damage.
2 secondary outcomes
Vessel wall integrity
Time frame: six months
Patency of internal thoracic arteries as bypass grafts
Time frame: six months
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 27 Apr 2018.
- Derived from this study: PubMed 30305183Zientara 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.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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.