NCT01035034

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

December 21, 2009

Status Verified

December 1, 2009

Enrollment Period

3 years

First QC Date

December 17, 2009

Last Update Submit

December 18, 2009

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Composite of major adverse cardiac or cerebrovascular events (MACCE) including death, myocardial infarction, stroke and/or repeat revascularization.

    1 year

Secondary Outcomes (9)

  • Overall MACCE rate.

    30 days after procedure and 2 years after enrollment

  • Cardiac death.

    30 days after procedure, 1 and 2 years after enrollment

  • Documented myocardial infarction.

    30 days after procedure, 1 and 2 years after enrollment

  • Target lesion revascularization.

    30 days after procedure, 1 and 2 years after enrollment

  • Recurrence of Angina.

    1 and 2 years after enrollment

  • +4 more secondary outcomes

Study Arms (2)

One-stop hybrid coronary revasularization

EXPERIMENTAL

Percutaneous Coronary Intervention; Coronary Artery Bypass

Procedure: Hybrid MIDCAB/PCI

PCI with stenting

ACTIVE COMPARATOR

Percutaneous Coronary Intervention

Procedure: PCI with DES

Interventions

Hybrid MIDCAB/PCIPROCEDURE

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).

One-stop hybrid coronary revasularization
PCI with DESPROCEDURE

Polymer-based Sirolimus-Eluting Stents (SES)

PCI with stenting

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Beijing, Beijing Municipality, 100037, China

RECRUITING

Institute of cardiovascular diseases & Fuwai hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Shengshou Hu, M.D.

    China National Center for Cardiovascular Diseases

    STUDY DIRECTOR

Central Study Contacts

Shengshou Hu, M.D.

CONTACT

0086-8838-8359shengshouhu@yahoo.com

Zhe Zheng, M.D.

CONTACT

0086-8838-8359zhengzhefuwai@tom.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 17, 2009

First Posted

December 18, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2012

Last Updated

December 21, 2009

Record last verified: 2009-12

Locations

CN(2)