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EndoACAB vs PCI for LAD Revascularization (ENPILА)

Primary Purpose

Coronary Artery Disease, Cardiovascular Diseases, Myocardial Ischemia

Status

Unknown status

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

Endoscopic coronary arterial bypass

Percutaneous Coronary Intervention

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring CABG, EndoCAB, PCI

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Endoscopic coronary arterial bypass

Percutaneous Coronary Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Pain assessment

assessment of visual analogue scale E.C. Huskisson

Full Information

NCT ID

NCT03909581

First Posted

February 26, 2019

Last Updated

April 9, 2019

Sponsor

National Research Center of Surgery, Russia

1. Study Identification

Unique Protocol Identification Number

NCT03909581

Brief Title

EndoACAB vs PCI for LAD Revascularization

Acronym

ENPILА

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 10, 2018 (Actual)

Primary Completion Date

May 1, 2021 (Anticipated)

Study Completion Date

May 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Research Center of Surgery, Russia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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: Endoscopic coronary arterial bypass 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Cardiovascular Diseases, Myocardial Ischemia

Keywords

CABG, EndoCAB, PCI

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Endoscopic coronary arterial bypass

Arm Type

Active Comparator

Arm Description

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

Arm Title

Percutaneous Coronary Intervention

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Endoscopic coronary arterial bypass

Other Intervention Name(s)

EndoCAB

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Percutaneous Coronary Intervention

Other Intervention Name(s)

PCI

Intervention Description

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

Primary Outcome Measure Information:

Title

MACCE

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Procedural success

Description

The treatment will be considered successful when a complete hybrid revascularisation in the absence of complications during the index hospitalization has been achieved.

Time Frame

1 year

Title

Pain assessment

Description

assessment of visual analogue scale E.C. Huskisson

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

+79166106609

drpopov@mail.ru

Facility Information:

Facility Name

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

City

Moscow

ZIP/Postal Code

117997

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vadim A Popov

Phone

+7 9166706609

drpopov@mail.ru

First Name & Middle Initial & Last Name & Degree

Vadim A. Popov

12. IPD Sharing Statement

Plan to Share IPD

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EndoACAB vs PCI for LAD Revascularization

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