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Comparison of One-stop Hybrid Revascularization Versus Off-pump Coronary Artery Bypass for the Treatment of Multi-vessel Disease

NCT ID: NCT01034371

Last Updated: 2009-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Brief Summary

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The "one-stop" hybrid coronary revascularization combines minimally invasive direct coronary artery bypass (MIDCAB) and PCI to be performed in the hybrid operating suite, an enhanced operating room equipped with radiographic capability. This study is to compare 1-year clinical outcomes of "one-stop" hybrid coronary revascularization with off-pump coronary artery bypass (OPCAB) in selected patients with multivessel coronary artery disease.

Detailed Description

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\- With the development of specialized devices and experience, off-pump coronary artery bypass (OPCAB) has been a well-established less invasive technique for coronary revascularization. Compared with conventional on-pump coronary artery bypass grafting (CABG), OPCAB avoids the use of cardiopulmonary bypass and cardioplegic arrest, and is associated with decreased morbidity, shorter length of stay in ICU and hospital, and less perioperative complications, especially in elderly patients with severe comorbidities. "One-stop" (also named simultaneous) hybrid coronary revascularization is also a novel, safe and feasible minimally invasive approach in selected patients with multivessel coronary artery disease (CAD). It allows surgical and interventional procedures to be performed consecutively in the "one-stop" hybrid operating suite, an enhanced operating room equipped with radiographic capability, wherein the left intramammary artery (LIMA) is placed on the left anterior descending artery (LAD) by minimally invasive procedure, immediately followed by percutaneous coronary intervention/stenting on the non-LAD lesions. However, few studies are now available on the outcomes of coronary revascularization between the new hybrid strategy with conventional OPCAB. This study is a single center randomized clinical trial to compare 1-year clinical outcomes of "one-stop" hybrid coronary revascularization with OPCAB in selected patients with multivessel CAD with suitable coronary anatomy.

Sample size:

\- We examined the results of SYNTAX trial and of our institution published previously. The 1-year MACCE rate (the primary endpoint) is estimated as being 13% for OPCAB. The sample calculated for this trial is 400 patients.

Design/Methodology:

\- Trial design: A single center randomized clinical trial comparing "one-stop" hybrid procedure versus conventional OPCAB in 400 patients with suitable anatomy who need revascularization.

Intervention: Patients will be randomized to undergo either "one-stop" hybrid procedure or conventional OPCAB.

\- Randomization: Patients will be evaluated by both a cardiac surgeon and an interventional cardiologist. After obtaining informed written consent, patients will be randomized to receive "one-stop" hybrid procedure or conventional OPCAB. An expertise-based randomization will be used.

The data adjudicators will be blinded to the study. Due to the nature of this study, the operating surgeons, cardiologists, anesthetists, other operative room staff, and ICU staff will not be blind in this study.

Study intervention:

\- Candidates will be randomized to receive "one-stop" hybrid procedure or conventional OPCAB.

Conditions

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Coronary Artery Disease

Keywords

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Coronary Artery Disease; Hybrid Revascularization; Percutaneous Coronary Intervention; Coronary Artery Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One-stop hybrid revasularization

Group Type EXPERIMENTAL

Minimally invasive direct coronary artery bypass

Intervention Type PROCEDURE

MIDCAB with no associated or concomitant surgical procedures, using partial ministernotomy, without cardiopulmonary bypass (CPB) and cardioplegia.

PCI-Drug eluting stents

Intervention Type PROCEDURE

PCI with drug eluting stents (DES) performed by cardiologists on the non-LAD lesions in the same operating suite immediately following MIDCAB.

Device: Polymer-based Sirolimus-Eluting Stents (SES).

Off-pump coronary artery bypass

Group Type ACTIVE_COMPARATOR

Off-pump coronary artery bypass

Intervention Type PROCEDURE

Procedure: coronary artery bypass without cardiopulmonary Coronary artery bypass surgery with no associated or concomitant surgical procedures, using full median sternotomy, without cardiopulmonary bypass (CPB) and cardioplegia.

Interventions

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Minimally invasive direct coronary artery bypass

MIDCAB with no associated or concomitant surgical procedures, using partial ministernotomy, without cardiopulmonary bypass (CPB) and cardioplegia.

Intervention Type PROCEDURE

PCI-Drug eluting stents

PCI with drug eluting stents (DES) performed by cardiologists on the non-LAD lesions in the same operating suite immediately following MIDCAB.

Device: Polymer-based Sirolimus-Eluting Stents (SES).

Intervention Type PROCEDURE

Off-pump coronary artery bypass

Procedure: coronary artery bypass without cardiopulmonary Coronary artery bypass surgery with no associated or concomitant surgical procedures, using full median sternotomy, without cardiopulmonary bypass (CPB) and cardioplegia.

Intervention Type PROCEDURE

Other Intervention Names

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MIDCAB PCI OPCAB

Eligibility Criteria

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Inclusion Criteria

* Two- or three-vessel disease, left main disease, or LM equivalent with 2 or 3-vessel disease (left anterior descending \[LAD\], left circumflex \[LCX\], right coronary artery \[RCA\] territory);
* LAD diseases not suitable for PCI \[i.e. chronic totally occlusion (CTO), severe calcification or/and angulated lesions, bifurcation or trifurcation lesions\];
* Angiographic characteristics of non-LAD lesion(s) amiable to PCI;
* Chronic stable or unstable angina pectoris of CCS 2 or greater (symptoms of angina and/or objective evidence of myocardial ischemia);
* Evaluated by both cardiac surgeon and cardiologist together.

Exclusion Criteria

* Need for emergent CABG;
* Prior CABG;
* Prior PCI with stenting within 6 months of study entry;
* Stroke with 6 months of study entry;
* Overt congestive heart failure;
* Need for a concomitant operation (i.e. valve repair or replacement, Maze surgery);
* Hemodynamic instability;
* Situations in which complete revascularization is not possible served;
* Allergy to radiographic contrast, aspirin or clopidogrel.
* Contradictions to PCI: Occluded coronary vessels, PVD, Unable to achieve access, Fresh thrombus, Vessels \<1.5mm; Intolerance to aspirin or both clopidogrel and ticlopidine;
* Cannot undergo either CABG or PCI/DES because of a coexisting medical condition
* History of significant bleeding; Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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China National Center for Cardiovascular Diseases

Principal Investigators

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Shengshou Hu, M.D.

Role: STUDY_DIRECTOR

China National Center for Cardiovascular Diseases

Locations

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China National Center for Cardiovascular Diseases, Cardiovascular Institute & Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Institute of cardiovascular diseases & Fuwai hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shengshou Hu, M.D.

Role: CONTACT

Phone: 0086-10-8839-8359

Email: [email protected]

Zhe Zheng, M.D.

Role: CONTACT

Phone: 0086-10-8839-8359

Email: [email protected]

Facility Contacts

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Shengshou Hu, M.D.

Role: primary

Zhe Zheng, M.D.

Role: backup

Shengshou Hu, M.D.

Role: primary

Zhe Zheng, M.D.

Role: backup

Other Identifiers

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20091216

Identifier Type: -

Identifier Source: org_study_id