Radial vs Vena No-Touch Assessment
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: radial artery graft, no-touch vein graft.
- Кому может быть актуально
- Состояния в реестре: Coronary Artery Atherosclerosis. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Россия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Comparative Study of the Effectiveness of Radial Artery and No-touch Vein in Coronary Artery Bypass Grafting in Women
Обзор
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.
Подробное описание
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:
1. Difference in the composite rate of major adverse cardiac and cerebrovascular events (MACCE) between the groups at 30 days and 12 months after the procedure. For the purposes of this study, MACCE components include all-cause mortality, stroke, myocardial infarction and/or repeat revascularization. 2. Difference in the incidence of complications (hemorrhagic, neurological, infectious, arrhythmological) between the groups. 3. Difference in angina class between the groups at one year after the procedure.
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.
Вмешательства
- Процедура radial artery graft
Circumflex artery territory revascularization using the radial artery graft - Процедура no-touch vein graft
Circumflex artery territory revascularization using a no-touch vein graft
Первичные конечные точки
- The ratio of functioning and closed shunts in both groups [Срок оценки: during follow-up time - 12 months]
Вторичные конечные точки (3)
- Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) (number of cases) [Срок оценки: Early postoperative (up to 2 weeks)/ Remote postoperative (up to 2 months)]
- Complications (percent) [Срок оценки: Early postoperative (up to 2 weeks)]
- Change in angina class (percent) [Срок оценки: Through study completion, an average of 1 year]
Критерии участия
Критерии включения
- Three-vessel disease involving the target circumflex artery with stenosis ≥70% and a diameter ≥1.5 mm
- Females aged 18 years and older
- Signed informed consent
- Clinical indications for coronary revascularization (refractory angina/transient myocardial ischemia according to noninvasive tests)
Критерии исключения
- Previous cardiac surgery of any type, including CABG
- Combined procedures
- Ineligibility for venous or radial artery harvesting as determined by preoperative Doppler flowmetry or clinical examination that would compromise graft patency.
- Acute myocardial ischemia
- EF less than 35%
- CKD 4.5
- Inability to understand the nature, scope, and consequences of the clinical trial, or to provide written informed consent due to cognitive impairment or mental illness.
- Life expectancy less than 1 year due to non-cardiac diseases.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Россия · 1 центр
- Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of — Tomsk
Идентификаторы
NCT: NCT07552948 · 294