Coronary Artery DiseaseNCT03753048
Total Arterial Revascularization (TAR)
A study testing Y-Graft and In-Situ in people with Coronary Artery Disease and Coronary Artery Bypass Grafting, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Total arterial revascularisation with in-situ confihuration of BITA is superior than y-graft in patients underwent CABG. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Bypass Grafting
- What is being tested?
- Y-Graft and In-Situ
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 1 siteRussia
- Study dates
- 13 Mar 2018to Mar 2024
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary Artery Disease
- Stable angina
- The need for revascularization of anterior descending and obtuse margin arteries accoring to the 2018 ESC/EACTS Guidelines on myocardial revascularization
- Informed Consent Form
Who cannot join
- The diameter of the target arteries is less than 1 mm
- Stenosis of the subclavian arteries more than 60%
- STEMI less than 3 month
- Previous cardiac surgery
- BMI >35
- COPD with FEV1 <60%
- Concomitant pathology that requires simultaneous surgical treatment
- Cancer with life expectancy less than 5 years
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Meshalkin National Medical Research Center
Novosibirsk, Novosibirsk Oblast, 630055
Dmitry A Sirota, MD, +79132012140, sirotad@yandex.ru
Dmitry Khvan, +79069090505, dmhvan@mail.ru
About this study
Official title: Comparison of Total Arterial Revascularization of Y-Graft Versus In-Situ Configuration Using Bilateral Internal Thoracic Arteries
Total arterial revascularisation with in-situ confihuration of BITA is superior than y-graft in patients underwent CABG.
Read the detailed description
The main hypothesis of the trial is that in-situ configuration of bilateral internal thoracic arteries is superior than Y-graft configuration for MACCE (mortality, myocardial infarction, repeat revascularization, stroke) during mid-term follow-up in patients with CAD who is shedueled for CABG.
- Being tested
- Y-Graft, In-Situ
- Keywords
- Total Arterial Revascularization, Y-Graft, In-Situ, Coronary Artery Bypass Grafting
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-GraftProcedure or surgery
Y-Graft Configuration Using BITA. Surgery can be performed off-pump or on the CPB. Both internal thoracic arteries should be harvested in semi-sceletonized fashion. After the administration of 3 mg/kg i/v UFH, the left internal thoracic artery is cut off distally and the right internal thoracic artery is cut off proximally and distally. Then they anastomose the following way. Left internal thoracic artery should be anastomosed to the left anterior descending artery (LAD) at first. Secondly, distal part of the right internal thoracic artery should be anastomosed to the obtuse marginal artery. Finally, proximal part of the right internal thoracic artery is anastomosed to the left internal thoracic artery as Y-graft in the end to side fashion. If it is nessesary, the right coronary artery system can be bypassed by separate autoarterial (eg. radial artery) or autovenous graft with proximal anastomose to the aorta.
In-SituProcedure or surgery
In-Situ Configuration Using BITA. Surgery can be performed off-pump or on the CPB. Both internal thoracic arteries should be harvested in semi-sceletonized fashion. After the administration of 3 mg/kg i/v UFH, both internal thoracic arteries are cut off distally. Then they anastomose the following way. Right internal thoracic artery should be anastomosed to the left anterior descending artery (LAD) at first. Secondly, left internal thoracic artery should be anastomosed to the obtuse marginal artery. If it is nessesary, the right coronary artery system can be bypassed by separate autoarterial (eg. radial artery) or autovenous graft with proximal anastomose to the aorta.
| Study group | Role | What they receive |
|---|---|---|
| Y-Graft | Active comparator | The group includes patients who underwent CABG in Y-Graft Configuration. Receives: Procedure: Y-Graft |
| In-Situ | Active comparator | The group includes patients who underwent CABG in In-Situ Configuration. Receives: Procedure: In-Situ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from MACCE
Composite MACCE (mortality, myocardial infarction, repeated revascularization, stroke)
Measured: 5 years
Secondary outcomes (3)
Graft patency
Graft patency in 5 years
Measured: 5 years
Quality of life (SF-36)
Assessment of the patient's quality of life by the Short Form-36 in 5 years
Measured: 5 years
Treadmill stress test
Non-invasive diagnosis of myocardial ischemia
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start13 Mar 2018
- Primary completionMar 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Collaborators
- Kemerovo Cardiology Center
- Responsible party
- Principal investigator, Dmitry Sirota, Meshalkin Research Institute of Pathology of Circulation
- Investigators
- Dmitry Sirota, MD, Principal investigator, Meshalkin National Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753048
- Sponsor's protocol ID
- TAR
- Status last verified
- Dec 2018
- First submitted
- 21 Nov 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Total Arterial Revascularization of Y-Graft Versus In-Situ Configuration Using Bilateral Internal Thoracic Arteries
- ClinicalTrials.gov ID
- NCT03753048
- Acronym / sponsor ID
- TAR
- Keywords
- Total Arterial Revascularization, Y-Graft, In-Situ, Coronary Artery Bypass Grafting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Collaborators
- Kemerovo Cardiology Center
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 26 Nov 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.
Total arterial revascularisation with in-situ confihuration of BITA is superior than y-graft in patients underwent CABG.
Detailed description
The main hypothesis of the trial is that in-situ configuration of bilateral internal thoracic arteries is superior than Y-graft configuration for MACCE (mortality, myocardial infarction, repeat revascularization, stroke) during mid-term follow-up in patients with CAD who is shedueled for CABG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Y-Graft | Active comparator | Procedure: Y-GraftThe group includes patients who underwent CABG in Y-Graft Configuration. |
| In-Situ | Active comparator | Procedure: In-SituThe group includes patients who underwent CABG in In-Situ Configuration. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Coronary Artery Disease
- Stable angina
- The need for revascularization of anterior descending and obtuse margin arteries accoring to the 2018 ESC/EACTS Guidelines on myocardial revascularization
- Informed Consent Form
Key exclusion criteria (8 listed)
- The diameter of the target arteries is less than 1 mm
- Stenosis of the subclavian arteries more than 60%
- STEMI less than 3 month
- Previous cardiac surgery
- BMI >35
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 |
|---|---|---|
| Y-GraftY-Graft Configuration Using BITA. Surgery can be performed off-pump or on the CPB. Both internal thoracic arteries should be harvested in semi-sceletonized fashion. After the administration of 3 mg/kg i/v UFH, the left internal thoracic artery is cut off distally and the right internal thoracic artery is cut off proximally and distally. Then they anastomose the following way. Left internal thoracic artery should be anastomosed to the left anterior descending artery (LAD) at first. Secondly, distal part of the right internal thoracic artery should be anastomosed to the obtuse marginal artery. Finally, proximal part of the right internal thoracic artery is anastomosed to the left internal thoracic artery as Y-graft in the end to side fashion. If it is nessesary, the right coronary artery system can be bypassed by separate autoarterial (eg. radial artery) or autovenous graft with proximal anastomose to the aorta. | Procedure or surgery | Y-Graft |
| In-SituIn-Situ Configuration Using BITA. Surgery can be performed off-pump or on the CPB. Both internal thoracic arteries should be harvested in semi-sceletonized fashion. After the administration of 3 mg/kg i/v UFH, both internal thoracic arteries are cut off distally. Then they anastomose the following way. Right internal thoracic artery should be anastomosed to the left anterior descending artery (LAD) at first. Secondly, left internal thoracic artery should be anastomosed to the obtuse marginal artery. If it is nessesary, the right coronary artery system can be bypassed by separate autoarterial (eg. radial artery) or autovenous graft with proximal anastomose to the aorta. | Procedure or surgery | In-Situ |
Primary outcome
Freedom from MACCE
Time frame: 5 years
Composite MACCE (mortality, myocardial infarction, repeated revascularization, stroke)
3 secondary outcomes
Graft patency
Time frame: 5 years
Quality of life (SF-36)
Time frame: 5 years
Treadmill stress test
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
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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.
Dmitry Sirota, MD principal investigator
Meshalkin National Medical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Y-Graft and In-Situ in people with Coronary Artery Disease and Coronary Artery Bypass Grafting, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 Dec 2018. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dmitry A Sirota, MD (+79132012140, sirotad@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from MACCE (time frame: 5 years). 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 11 Dec 2018.