NCT03909581

EndoACAB vs PCI for LAD Revascularization

Randomized Study Of Endoscopic Coronary Arterial Bypass Versus Percutaneous Coronary Intervention for Left Anterior Descending Artery Revascularization

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Research Center of Surgery, Russia · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine which treatment option is better for patients who have isolated coronary artery disease (blockages of one vessel supplying blood to the heart muscle). The treatment options compared in this study are: 1. Endoscopic coronary arterial bypass 2. Percutaneous Coronary Intervention. This study is aimed to determine the best treatment for patients with coronary artery disease.

Detailed description

Coronary artery disease (CAD), also known as coronary heart disease (CHD) involves the progressive narrowing of the arteries that nourish the heart muscle. CAD is the main cause of death in Russia. Patients with LAD disease have worse coronary flow outcomes Currently established types of myocardial revascularization are coronary artery bypass grafting (CABG) and percutaneous coronary interventions (PCI). High effectiveness of CABG was proved by multiple studies. PCI is a first line therapy in the treatment of one vessel disease due to the less invasive approach and current technological possibilities of this revascularization method. However, the established gold standard of multivessel coronary blockage treatment is CABG. It was reflected in the latest ESC/EACTS Guidelines on Myocardial Revascularization, due to the better early and late outcomes associated with the graft specifics. On the other hand, standard CABD operation has a high injury and morbidity rate, which were factors for development of less invasive techniques of CABG. According to the latest ESC/EACTS guidelines there are no advantages between PCI and CABG in the LAD disease treatment, both methods are Class I; level of evidence A. The choice between myocardial revascularization methods in patients with LAD disease is the critical task.

Conditions

• Coronary Artery Disease
• Cardiovascular Diseases
• Myocardial Ischemia

Interventions

Type	Name	Description
PROCEDURE	Endoscopic coronary arterial bypass	is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization (50 participants)
PROCEDURE	Percutaneous Coronary Intervention	will be performed using standard techniques at the discretion of the operator (50 participants)

Timeline

• Start date: 2018-02-10
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2019-04-10
• Last updated: 2019-04-10

Locations

1 site across 1 country: Russia