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Status unknownNCT02894255Updated Sep 9, 2016

Prospective Multicenter Registry of Hybrid Coronary Artery Revascularization Combined With Surgical Bypass and Percutaneous Coronary Intervention Using Everolimus Eluting Metallic Stents

A Phase 4 interventional study of Coronary artery bypass grafting and Percutaneous coronary intervention in Coronary Artery Disease, sponsored by Teikyo University. Status unknown. Per ClinicalTrials.gov, last updated 2016-09-09.

Sponsored by Teikyo University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Sex
All
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Study summary

This prospective multicenter registry evaluates the efficacy of hybrid coronary revascularization (HCR) combining coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI) in the treatment of multivessel coronary artery disease. CABG is to be performed in the left anterior descending artery and the left circumflex artery using only arterial grafts, whereas PCI is to be conducted for the treatment of significant stenotic disease in the right coronary artery with everolimus-eluting stents (EESs). This research plans to involve patients scheduled for coronary revascularization for multivessel coronary artery disease who consent to participate in the registry.

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Conditions studied

  • Coronary Artery Disease
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 100 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Teikyo University is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with stable angina, unstable angina, or non-ST elevation myocardial infarction.

    • Patients with multivessel coronary artery disease including significant stenotic lesion* in the right coronary artery and also including left main stem disease.
    • Patients who will be referred for CABG.
    • Patients with significant stenotic lesion in the right coronary artery amenable to PCI.
    • Patients who can take DAPT medications.
    • Patients who provided written informed consent. * Significant stenotic lesion means a condition where fractional flow reserve (FFR) is lower than 0.80 or visually confirmed stenosis is at least 75%.

Exclusion criteria

Exclusion Criteria:

    • Patients with ST elevation myocardial infarction occurring within 24 hours before enrollment.

      • Patients who previously underwent CABG.
      • Patients who are at high risk of receiving CABG.
      • Patients who need simultaneous surgery such as valve surgery other than CABG.
      • Patients with a life expectancy of 1 year or shorter due to co-morbidities.
      • Patients with a history of cerebral infarction within the last 6 months.
      • Patients with congestive cardiac failure of NYHA 3 or higher.
      • Patients with unstable hemodynamics at enrollment.
      • Patients with right coronary artery disease that is chronic total occlusion and difficult to treat with PCI (J-CTO score of ≥ 23).
      • Patients receiving long-term dialysis.
      • Patients who are allergic to antiplatelet agent.
      • Patients who are critically allergic to contrast media.
      • Patients who are allergic to any DES component.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    PCI and CABG

    Device: Coronary artery bypass grafting · Procedure: Percutaneous coronary intervention

Interventions

  • DeviceCoronary artery bypass grafting
  • ProcedurePercutaneous coronary intervention
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What researchers measure

Primary outcomes

  1. Major adverse cardiovascular event (death, myocardial infarction, cerebrovascular disorder, and repeat revascularization)

    Time frame: 12 months

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02894255
Lead sponsor
Teikyo University
Responsible party
Ken Kozuma (Professor, Teikyo University) — Principal investigator
First posted
Sep 9, 2016
Start date
Sep 2016
Primary completion
Sep 2017 (estimated)
Last update
Sep 9, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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