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
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring CABG, EndoCAB, PCI
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
Sites / Locations
- A.V. Vishnevsky National Medical Research Center of Surgery.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
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
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
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
No
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
Email
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
Email
drpopov@mail.ru
First Name & Middle Initial & Last Name & Degree
Vadim A. Popov
12. IPD Sharing Statement
Plan to Share IPD
No
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EndoACAB vs PCI for LAD Revascularization
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