Trial record 2 of 197 for:    Open Studies | coronary artery bypass

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by China National Center for Cardiovascular Diseases.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT01034371
First received: December 16, 2009
Last updated: December 18, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Procedure: Minimally invasive direct coronary artery bypass
Procedure: PCI-Drug eluting stents
Procedure: Off-pump coronary artery bypass

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of "One-stop" Hybrid Coronary Revascularization Versus Off-pump Coronary Artery Bypass for the Treatment of Multi-vessel Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by China National Center for Cardiovascular Diseases:

Primary Outcome Measures:
  • Composite of major adverse cardiac or cerebrovascular events (MACCE) including death, myocardial infarction, stroke and/or repeat revascularization. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall MACCE rate. [ Time Frame: 30 days after procedure and 2 years after enrollment ] [ Designated as safety issue: Yes ]
  • Cardiac death. [ Time Frame: 30 days after procedure, 1 and 2 years after enrollment ] [ Designated as safety issue: Yes ]
  • Documented myocardial infarction. [ Time Frame: 30 days after procedure, 1 and 2 years after enrollment ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization. [ Time Frame: 30 days after procedure, 1 and 2 years after enrollment ] [ Designated as safety issue: Yes ]
  • Recurrence of Angina. [ Time Frame: 1 and 2 years after enrollment ] [ Designated as safety issue: Yes ]
  • Cost-effectiveness analysis. [ Time Frame: 1 and 2 years after enrollment ] [ Designated as safety issue: Yes ]
  • Quality of life. [ Time Frame: 6 months, 1 and 2 years after enrollment ] [ Designated as safety issue: Yes ]
  • Rehospitalization. [ Time Frame: 6 months, 1 and 2 years after enrollment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: December 2009
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: One-stop hybrid revasularization Procedure: Minimally invasive direct coronary artery bypass
MIDCAB with no associated or concomitant surgical procedures, using partial ministernotomy, without cardiopulmonary bypass (CPB) and cardioplegia.
Other Name: MIDCAB
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).

Other Name: PCI
Active Comparator: Off-pump coronary artery bypass 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.
Other Name: OPCAB

Detailed Description:

- 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034371

Contacts
Contact: Shengshou Hu, M.D. 0086-10-8839-8359 shengshouhu@yahoo.com
Contact: Zhe Zheng, M.D. 0086-10-8839-8359 zhengzhefuwai@tom.com

Locations
China, Beijing
Institute of cardiovascular diseases & Fuwai hospital Recruiting
Beijing, Beijing, China, 100037
Contact: Shengshou Hu, M.D.    0086-10-8839-8359    shengshouhu@yahoo.com   
Contact: Zhe Zheng, M.D.    0086-10-8839-8359    zhengzhefuwai@tom.com   
Principal Investigator: Shengshou Hu, M.D.         
Principal Investigator: Yuejin Yang, M.D.         
China National Center for Cardiovascular Diseases, Cardiovascular Institute & Fuwai Hospital Recruiting
Beijing, Beijing, China, 100037
Contact: Shengshou Hu, M.D.    0086-010-8839-8359    shengshouhu@yahoo.com   
Contact: Zhe Zheng, M.D.    0086-010-8839-8359    zhengzhefuwai@tom.com   
Principal Investigator: Shengshou Hu, M.D.         
Principal Investigator: Yuejin Yang, M.D.         
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Investigators
Study Director: Shengshou Hu, M.D. China National Center for Cardiovascular Diseases
  More Information

No publications provided

Responsible Party: China National Center for Cardiovascular Diseases ( Shengshou Hu MD, FACC ), China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT01034371     History of Changes
Other Study ID Numbers: 20091216
Study First Received: December 16, 2009
Last Updated: December 18, 2009
Health Authority: China: Ministry of Health

Keywords provided by China National Center for Cardiovascular Diseases:
Coronary Artery Disease; Hybrid Revascularization;
Percutaneous Coronary Intervention; Coronary Artery Bypass

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014