Comparison of One-stop Hybrid Revascularization Versus Percutaneous Coronary Intervention for the Treatment of Multi-vessel Disease
NCT ID: NCT01035034
Last Updated: 2009-12-21
Study Results
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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UNKNOWN
NA
480 participants
INTERVENTIONAL
2009-12-31
Brief Summary
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Detailed Description
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"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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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One-stop hybrid coronary revasularization
Percutaneous Coronary Intervention; Coronary Artery Bypass
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).
PCI with stenting
Percutaneous Coronary Intervention
PCI with DES
Polymer-based Sirolimus-Eluting Stents (SES)
Interventions
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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).
PCI with DES
Polymer-based Sirolimus-Eluting Stents (SES)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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China National Center for Cardiovascular Diseases
OTHER_GOV
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
Institute of cardiovascular diseases & Fuwai hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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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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20091217
Identifier Type: -
Identifier Source: org_study_id