EndoACAB vs PCI for LAD Revascularization

Coronary Artery Disease Clinical Trial

— ENPIL?  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03909581
• Other study ID #: 7t7sci9q
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2018
• Est. completion date: May 1, 2021

Study information

• Verified date: April 2019
• Source: National Research Center of Surgery, Russia
• Contact: Vadim A Popov, MD. Ph.D. Prof.
• Phone: +79166106609
• Email: drpopov[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Myocardial Ischemia

Intervention

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)
• Percutaneous Coronary Intervention
will be performed using standard techniques at the discretion of the operator (50 participants)

Locations

Country	Name	City	State
Russian Federation	A.V. Vishnevsky National Medical Research Center of Surgery.	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
National Research Center of Surgery, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Procedural success	The treatment will be considered successful when a complete hybrid revascularisation in the absence of complications during the index hospitalization has been achieved.	1 year
Secondary	Pain assessment	assessment of visual analogue scale E.C. Huskisson	1 year