Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kemerovo Cardiology Center | OTHER |
Not provided
Not provided
Not provided
Not provided
Total arterial revascularisation with in-situ confihuration of BITA is superior than y-graft in patients underwent CABG.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Y-Graft | Active Comparator | The group includes patients who underwent CABG in Y-Graft Configuration. |
|
| In-Situ | Active Comparator | The group includes patients who underwent CABG in In-Situ Configuration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Y-Graft | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from MACCE | Composite MACCE (mortality, myocardial infarction, repeated revascularization, stroke) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Graft patency | Graft patency in 5 years | 5 years |
| Quality of life (SF-36) | Assessment of the patient's quality of life by the Short Form-36 in 5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dmitry A Sirota, MD | Contact | +79132012140 | sirotad@yandex.ru |
| Name | Affiliation | Role |
|---|---|---|
| Dmitry Sirota, MD | Meshalkin National Medical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meshalkin National Medical Research Center | Recruiting | Novosibirsk | Novosibirsk Oblast | 630055 | Russia |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| In-Situ | Procedure | 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. |
|
| 5 years |
| Treadmill stress test | Non-invasive diagnosis of myocardial ischemia | 5 years |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |