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This study examines the outcomes of coronary artery bypass grafting (CABG) in women at 1 year after surgery. A randomized controlled trial is planned, including a comparative analysis of two observed groups depending on the chosen conduit for revascularization of the circumflex artery. The main group is supposed to include 55 patients undergoing CABG with the use of the radial artery, while the control group will include 55 patients undergoing CABG with the use of the great saphenous vein prepared using the no-touch technique.
The Raventa trial is a prospective, unblinded, randomized single centre trial comprising 110 subjects. Women with left main and/or multivessel disease will be randomized to radial artery (RA) or no-touch vein (NV) grafts to the left coronary system in a 1:1 fashion. The primary outcome will be the ratio of functioning and closed radial artery and no-touch vein bypass grafts in the groups one year after surgery. The secondary outcomes will be:
In all patients, 1 internal thoracic artery will be anastomosed to the left anterior descending coronary artery. For patients randomized to the NV group, saphenous no-touch vein grafts will be used for all non-left anterior descending target vessels. For patients randomized to the RA group, the main target vessel of the lateral wall will be grafted with radial artery. Additional grafts can be saphenous veins or supplemental arterial conduits at the surgeon's discretion.
Screening. The screening period will last from the patient's admission to the hospital until the day before surgery. Eligibility for this study will be determined based on the results of routine clinical and instrumental examinations, conducted in accordance with existing clinical practice standards and the Cardiology Research Institute's protocols for this patient category, including coronary angiography, ultrasound, and general clinical tests.
Follow-up period: 12 months after surgery. During this period, information on the disease course and intervention outcomes will be collected. Data on secondary endpoints 1 and 2 will be collected within 30 days postoperatively. A follow-up assessment of the study participants' vital status will be performed in 12 months after surgery, identifying MACCE (all-cause mortality, repeat revascularization, stroke, and myocardial infarction) as well as examining coronary bypasses to assess the primary endpoint and secondary endpoints 1 and 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radial artery | Active Comparator | Radial artery as a conduit for the circumflex artery territory in 55 patients undergoing coronary artery bypass grafting |
|
| No-touch great saphenous vein | Active Comparator | No-touch great saphenous vein graft for revascularization of the circumflex artery territory in 55 patients during coronary artery bypass grafting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radial artery graft | Procedure | Circumflex artery territory revascularization using the radial artery graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| The ratio of functioning and closed shunts in both groups | during follow-up time - 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) (number of cases) | Between groups at 30 days and 12 months after surgery. | Early postoperative (up to 2 weeks)/ Remote postoperative (up to 2 months) |
| Complications (percent) |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vasily V. Zatolokin, PhD | Contact | +79138490545 | zatolokin@cardio-tomsk.ru | |
| Danil V. Timofeev | Contact | +79059937497 | 3120v@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Yuri Y. Veshersky, MD, PhD | Cardiology Research Institute, Tomsk National Research Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia | Recruiting | Tomsk | 634012 | Russia |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| no-touch vein graft | Procedure | Circumflex artery territory revascularization using a no-touch vein graft |
|
Complication rates between groups
| Early postoperative (up to 2 weeks) |
| Change in angina class (percent) | one year after surgical revascularization in the compared groups | Through study completion, an average of 1 year |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |