Comparison of One-stop Hybrid Revascularization Versus Percutaneous Coronary Intervention for the Treatment of Multi-vessel Disease

December 18, 2009 updated by: China National Center for Cardiovascular Diseases

Comparison of "One-stop" Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention for the Treatment of Multi-vessel Coronary Artery Disease

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • China National Center for Cardiovascular Diseases, Cardiovascular Institute & Fuwai Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shengshou Hu, M.D.
        • Principal Investigator:
          • Yuejin Yang, M.D.
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Institute of cardiovascular diseases & Fuwai hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shengshou Hu, M.D.
        • Principal Investigator:
          • Yuejin Yang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of major adverse cardiac or cerebrovascular events (MACCE) including death, myocardial infarction, stroke and/or repeat revascularization.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall MACCE rate.
Time Frame: 30 days after procedure and 2 years after enrollment
30 days after procedure and 2 years after enrollment
Cardiac death.
Time Frame: 30 days after procedure, 1 and 2 years after enrollment
30 days after procedure, 1 and 2 years after enrollment
Documented myocardial infarction.
Time Frame: 30 days after procedure, 1 and 2 years after enrollment
30 days after procedure, 1 and 2 years after enrollment
Target lesion revascularization.
Time Frame: 30 days after procedure, 1 and 2 years after enrollment
30 days after procedure, 1 and 2 years after enrollment
Recurrence of Angina.
Time Frame: 1 and 2 years after enrollment
1 and 2 years after enrollment
Cost-effectiveness analysis.
Time Frame: 1 and 2 years after enrollment
1 and 2 years after enrollment
Quality of life.
Time Frame: 6 months, 1 and 2 years after enrollment
6 months, 1 and 2 years after enrollment
Rehospitalization.
Time Frame: 6 months, 1 and 2 years after enrollment
6 months, 1 and 2 years after enrollment
Stent thrombosis.
Time Frame: 30 days after procedure, 6 months, 1 and 2 years after enrollment
30 days after procedure, 6 months, 1 and 2 years after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Investigators

  • Study Director: Shengshou Hu, M.D., China National Center for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

December 17, 2009

First Submitted That Met QC Criteria

December 17, 2009

First Posted (Estimate)

December 18, 2009

Study Record Updates

Last Update Posted (Estimate)

December 21, 2009

Last Update Submitted That Met QC Criteria

December 18, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20091217

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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