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Набор по приглашению NCT06794359

Minimally Invasive Coronary Artery Bypass Surgery in Patients With Multi Vessel Coronary Disease

Без фазы С лечением Coronary Arterial Disease (CAD) Coronary Artery Bypass

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: Minimally Invasive Coronary Artery Bypass Grafting, Coronary artery bypass surgery.
Кому может быть актуально
Состояния в реестре: Coronary Arterial Disease (CAD), Coronary Artery Bypass. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бразилия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Minimally Invasive Coronary Artery Bypass Surgery: Prospective and Randomized Study to Validate the Minimally Invasive Approach Through Left Anterior Mini Thoracotomy in Patients With Milti Vessel Coronary Disease

Обзор

The objective of this study is to evaluate the safety and feasibility of Minimally Invasive Coronary Artery Bypass surgery in selected patients ,with multi vessel coronary disease. This trial is designed to be a pilot study that will gather comparative information on the clinical performance of the minimally invasive treatment, evaluated by the composite measure of all-cause death, myocardial infarction, stroke, or unplanned repeat revascularization - in hospital, 30-day and 6 months.

Подробное описание

Minimally invasive surgery has been a breakthrough in medicine, especially in more developed countries. It represents an evolution of current techniques associated with new technologic devices, that allow a safe and effective procedure associated to an aesthetic benefit.

Invasive treatment of coronary artery disease has been on a plateau lately. Percutaneous treatment that emerged as a promise to replace surgical methods, has already shown its limitations, even with the use of drug-eluting stents. Traditional CABG (coronary artery bypass grafting surgery), which has been considered the gold standard, has been criticized for its high degree of invasiveness.

Based on this precept, interest has emerged in creating a surgical approach that causes less trauma. Surgical access using minimally invasive incisions are gaining space and have shown less postoperative pain, shorter hospital stays, earlier mobilization and functional recovery, in addition to reducing the costs of the procedure.

Cardiac surgery has some challenges that are beyond other specialties. The heart is a vital organ with intrinsic chronotropism that lies inside a rigid rib cage.

Specifically, in coronary artery bypass graft surgery (CABG), the thin caliber of the coronaries and their distribution throughout the cardiac territories creates even a greater challenge. However, new surgical techniques associated with new devices, demonstrated the viability of complete revascularization through a limited access incision.

In an attempt to minimize surgical trauma and the morbidities caused by conventional median sternotomy and the use of On Pump surgery, some alternatives have emerged with promising results.

Among those efforts, we can highlight the beginning of the coronary artery grafting surgery without the use of cardiopulmonary bypass (Off Pump CABG), followed by hybrid revascularization, minimally invasive surgery by lateral thoracotomy under direct vision, partially assisted robot surgery and fully endoscopic surgery with using robots.

Currently, minimally invasive surgery though mini lateral thoracotomy is the most common technique used. Initially it was used only for the treatment of the left anterior descending artery (LAD), but technology advances and surgical improvement allowed complete revascularization under direct vision. Surgery can be performed with or without the aid of cardiopulmonary bypass (CPB), treatment individualization is necessecary for every case.

This is a pilot study to evaluate the safety and feasibility of Minimally Invasive Coronary Artery Bypass surgery in selected patients ,with multi vessel coronary disease.

Вмешательства

  • Процедура Minimally Invasive Coronary Artery Bypass Grafting
    Minimally Invasive Coronary Artery Bypass Grafting will be accomplished by complete revascularization of all previous defined coronary targets through left anterior thoracotomy. On or off pump approach will be determined by the surgeon. For on pump cases, femoral canulation will be performed and aortic cross clamp will be used. Off Pump cases will be performed using Medtronic Octopus and Starfish NS. Intra operative Transit time flow measurement will be performed in all cases.
  • Процедура Coronary artery bypass surgery
    Procedure: Conventional Coronary Artery Bypass Grafting will be accomplished by complete revascularization of all previous defined coronary targets through classical total sternotomy. On or off pump approach will be determined by the surgeon. Intra operative Transit time flow measurement will be performed in all cases.

Первичные конечные точки

  • Feasibility and safety of proposed revascularization through minimally invasive approach [Срок оценки: Clinical follow-up intra hospitalar, 30-day and 6 months]
Вторичные конечные точки (12)
  • Intraoperative conversion rate [Срок оценки: Intraoperative measure]
  • Complete revascularization rate [Срок оценки: Intraoperative measure]
  • Postoperative bleeding volume [Срок оценки: First 48 hours post-surgery]
  • Surgery duration [Срок оценки: Intraoperative measure]
  • Length of orotracheal intubation [Срок оценки: From oral intubation until extubation]
  • Length of ICU and hospital stay [Срок оценки: From ICU admission to discharge]
  • Intra operative graft evaluation [Срок оценки: This is a specific assessment carried out during the surgical procedure (intraoperative).]
  • Postoperative myocardial infarction [Срок оценки: Within 48 hours following surgery]
  • Surgical Mortality [Срок оценки: 30 days postoperatively]
  • Wound infection [Срок оценки: From the date of surgery through 30 days postoperatively.]
  • Post operatative atrial fibrillation [Срок оценки: Immediate postoperative: from the day of surgery to postoperative day 7. • Early late postoperative: from postoperative day 8 to day 30. • Late outpatient assessment: between 30 days and 6 months post-surgery.]
  • Neurological events [Срок оценки: Stroke related to surgery will be acessed in phases: • Immediate postoperative: from the day of surgery to postoperative day 7. • Early late postoperative: from postoperative day 8 to day 30. • Late outpatient assessment: between 30 days and 6 months po]

Критерии участия

Критерии включения

  • Patients 18-years-old or older
  • Isolated myocardial revascularization procedure
  • Double or Triple-vessel disease with proximal or mid LAD disease with angiographic diameter stenosis \> 70% by visual analysis in all territories, requiring myocardial revascularization OR proximal LAD disease with angiographic diameter stenosis 50-70% by visual analysis in any territory but with invasive or non-invasive evidence of flow-limiting stenosis in all three territories, requiring myocardial revascularization
  • Total SYNTAX score \> 22 or low Syntax score unsuitable for PCI
  • Clinical and anatomic eligibility for both Minimally invasive and Conventional CABG surgery as agreed to by surgical team.
  • Silent ischemia, stable angina, unstable angina or recent MI

\- If recent MI, cardiac biomarkers must have returned to normal prior to randomization

  • Ability to sign informed consent and comply with all study procedures

Критерии исключения

  • Reoperation
  • Need for any concomitant cardiac surgery other than CABG (e.g. valve surgery, aortic repair, etc.), or intent that if the patient randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed
  • Left ventricle disfunction (EF\<40%)
  • Chronic Pulmonary obstructive disease
  • Renal failure disease
  • Emergency surgery
  • Obesity
  • Sternum anatomic defects including pectus excavatum
  • Peripheral vascular disease
  • Ascending aorta severe calcification
  • Non cardiac co-morbidities with life expectancy less than 1 year

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

Бразилия · 1 центр
  • INCOR - Heart Institute from the University of Sao Paulo — São Paulo

Публикации

  • Palma Dallan LR, Ferreira Lisboa LA, Oliveira Dallan LA, Asdrubal Vilca Mejia O, Neves Filho AF, Doenst T, Babliak O, Orellana Sampedro GA, Jatene FB. Minimally invasive coronary artery bypass grafting (MINI-CABG): Protocol for a pilot randomized controlled trial comparing minimally invasive versus conventional coronary surgery. PLoS One. 2025 Dec 29;20(12):e0337829. doi: 10.1371/journal.pone.0337 PMID 41460930

Идентификаторы

NCT: NCT06794359 · CAAE 54175921.8.0000.0068 · 2021/11947-5

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗