Coronary Artery DiseaseENPILАNCT03909581
EndoACAB vs PCI for LAD Revascularization
A study testing Endoscopic coronary arterial bypass and Percutaneous Coronary Intervention in people with Coronary Artery Disease and Cardiovascular Diseases, run by National Research Center of Surgery, Russia at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Cardiovascular Diseases, Myocardial Ischemia
- What is being tested?
- Endoscopic coronary arterial bypass and Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 10 Feb 2018to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
A.V. Vishnevsky National Medical Research Center of Surgery.
Moscow, 117997
Vadim A Popov, +7 9166706609, drpopov@mail.ru
Vadim A. Popov
About this study
Official title: Randomized Study Of Endoscopic Coronary Arterial Bypass Versus Percutaneous Coronary Intervention for Left Anterior Descending Artery Revascularization
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.
Read the 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.
- Being tested
- Endoscopic coronary arterial bypass, Percutaneous Coronary Intervention
- Keywords
- CABG, EndoCAB, PCI
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic coronary arterial bypassProcedure or surgery
Also called EndoCAB
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 InterventionProcedure or surgery
Also called PCI
will be performed using standard techniques at the discretion of the operator (50 participants)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Endoscopic coronary arterial bypass |
| Percutaneous Coronary Intervention | Active comparator | will be performed using standard techniques at the discretion of the operator Receives: Procedure: Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 1 year
Pain assessment
assessment of visual analogue scale E.C. Huskisson
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start10 Feb 2018
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center of Surgery, Russia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vadim Popov, National Research Center of Surgery, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909581
- Sponsor's protocol ID
- 7t7sci9q
- Acronym
- ENPILА
- Status last verified
- Apr 2019
- First submitted
- 26 Feb 2019
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Of Endoscopic Coronary Arterial Bypass Versus Percutaneous Coronary Intervention for Left Anterior Descending Artery Revascularization
- ClinicalTrials.gov ID
- NCT03909581
- Acronym / sponsor ID
- ENPILА / 7t7sci9q
- Keywords
- CABG, EndoCAB, PCI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Research Center of Surgery, RussiaOther government
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic coronary arterial bypass | Active comparator | Procedure: Endoscopic coronary arterial bypassis defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization |
| Percutaneous Coronary Intervention | Active comparator | Procedure: Percutaneous Coronary Interventionwill be performed using standard techniques at the discretion of the operator |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic coronary arterial bypassAlso: EndoCABis defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization (50 participants) | Procedure or surgery | Endoscopic coronary arterial bypass |
| Percutaneous Coronary InterventionAlso: PCIwill be performed using standard techniques at the discretion of the operator (50 participants) | Procedure or surgery | Percutaneous Coronary Intervention |
Primary outcome
MACCE
Time frame: 1 year
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.
2 secondary outcomes
Procedural success
Time frame: 1 year
Pain assessment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic coronary arterial bypass and Percutaneous Coronary Intervention in people with Coronary Artery Disease and Cardiovascular Diseases, run by National Research Center of Surgery, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vadim A Popov, MD. Ph.D. Prof. (+79166106609, drpopov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.