EndoACAB vs PCI for LAD Revascularization

NCT03909581 | Unknown DMC

• 1 other identifier: 7t7sci9q
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.Endoscopic coronary arterial bypass
2. 2.Percutaneous Coronary Intervention. This study is aimed to determine the best treatment for patients with coronary artery disease.

Conditions

Coronary Artery Disease; Cardiovascular Diseases; Myocardial Ischemia

Keywords

CABG; EndoCAB; PCI

Outcome Measures

Primary Outcomes (1)

• MACCE

  Major adverse cardiac and cerebral events (MACCE), including death,a composite of major cardiac and cerebrovascular events, i.e. the first occurrence of any of the following events: Death from any cause From cardiovascular causes From noncardiovascular causes Stroke or transitory ischemic attack (TIA) MI Hospitalization for repeat revascularization procedure, target (vessel) revascularization by means of PCI or CABG.

  1 year

Secondary Outcomes (2)

• Procedural success

  1 year

• Pain assessment

  1 year

Study Arms (2)

Endoscopic coronary arterial bypass

ACTIVE COMPARATOR

is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization

Procedure: Endoscopic coronary arterial bypass

Percutaneous Coronary Intervention

ACTIVE COMPARATOR

will be performed using standard techniques at the discretion of the operator

Procedure: Percutaneous Coronary Intervention

Interventions

Endoscopic coronary arterial bypass PROCEDURE

is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization (50 participants)

Also known as: EndoCAB

Endoscopic coronary arterial bypass

Percutaneous Coronary Intervention PROCEDURE

will be performed using standard techniques at the discretion of the operator (50 participants)

Also known as: PCI

Percutaneous Coronary Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The presence of isolated lesions of LAD are available for revascularization PCI and EndoCAB
• Suitable candidate for both PCI and EndoCAB as determined by clinical assessment and angiogram review by an interventional cardiologist and a cardiac surgeon at the enrolling clinical site
• Age ≥ 18 years

You may not qualify if:

• Previous cardiac surgery of any kind, including CABG
• Previous thoracic surgery involving the left pleural space
• Need for concomitant vascular or other cardiac surgery during the index hospitalization (including, but not limited to, valve surgery, aortic resection, left ventricular aneurysmectomy, and carotid endarterectomy or stenting)
• Indication for chronic oral anticoagulation therapy at the time of randomization
• Extra-cardiac illness that is expected to limit survival to less than 5 years
• Allergy or hypersensitivity to any of the study drugs or devices used in the trial
• Therapy with an investigational drug, device or biologic within 1 year prior to randomization, or plan to enroll patient in additional investigational study during participation in this trial
• Unable to give informed consent or potential for noncompliance with the study protocol in the judgment of the investigator
• Ejection fraction of 40% or less Left ventricular dysfunction

Sponsors & Collaborators

• National Research Center of Surgery, Russia: lead

Study Sites (1)

A.V. Vishnevsky National Medical Research Center of Surgery.

Moscow, 117997, Russia

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Cardiovascular Diseases; Myocardial Ischemia

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Vadim A Popov, MD. Ph.D. Prof.

CONTACT

+79166106609; drpopov@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D, Prof. Head of cardiovascular Department

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: April 10, 2019
• Study Start: February 10, 2018
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: April 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)