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Comparison of One-stop Hybrid Revascularization Versus Percutaneous Coronary Intervention 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:
NCT01035034
First received: December 17, 2009
Last updated: December 18, 2009
Last verified: December 2009
History of Changes
  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 percutaneous coronary intervention (PCI) in selected patients with multivessel coronary artery disease.


Condition Intervention
Coronary Artery Disease
 Procedure: Hybrid MIDCAB/PCI
Procedure: PCI with DES

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 Percutaneous Coronary Intervention for the Treatment of Multi-vessel Coronary Artery Disease

Resource links provided by NLM:

U.S. FDA Resources

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 ]
  • Stent thrombosis. [ Time Frame: 30 days after procedure, 6 months, 1 and 2 years after enrollment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 480
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 coronary revasularization
Percutaneous Coronary Intervention; Coronary Artery Bypass
 Procedure: Hybrid MIDCAB/PCI

MIDCAB with no associated or concomitant surgical procedures, using partial ministernotomy, without cardiopulmonary bypass (CPB) and cardioplegia. 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).
Active Comparator: PCI with stenting
Percutaneous Coronary Intervention
 Procedure: PCI with DES
Polymer-based Sirolimus-Eluting Stents (SES)

Detailed Description:

Rationale and purpose of this study:

"One-stop" (also named simultaneous) hybrid coronary revascularization has emerged as a novel, safe and feasible minimally invasive approach in selected patients with multivessel coronary artery disease (CAD). The benefits of "one-stop" hybrid procedure compared with conventional PCI are unclear, however.

This study is a single center randomized clinical trial to compare the safety and efficacy of "one-stop" hybrid procedure with conventional PCI in the treatment of selected patients with multivessel CAD requiring revascularization with suitable coronary anatomy.

Sample size:

We examined the results of SYNTAX trial and of the hybrid procedures published previously. The 1-year MACCE rate (the primary endpoint) is estimated as being 18% for PCI/stenting and 8% for the hybrid group. The sample calculated for this trial is 480 patients.

Design/Methodology:

Trial design: A single center randomized clinical trial comparing "one-stop" hybrid procedure versus conventional PCI with SES in 480 patients with suitable anatomy who need revascularization.

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

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 PCI with SES. 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 PCI.

  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)
  • Denovo lesions of LAD , with obstruction >=70%, especially chronic totally occlusion (CTO), severe calcification or bifurcation lesion of the LM;
  • Angiographic characteristics of non-LAD lesion(s) amiable to PCI/stenting;
  • 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: NCT01035034

Contacts
Contact: Shengshou Hu, M.D. 0086-8838-8359 shengshouhu@yahoo.com
Contact: Zhe Zheng, M.D. 0086-8838-8359 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: NCT01035034     History of Changes
Other Study ID Numbers: 20091217
Study First Received: December 17, 2009
Last Updated: December 18, 2009
Health Authority: China: Ministry of Health

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 May 19, 2013