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

NCT02894255 | Unknown Phase 4

• 1 other identifier: 15-233
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

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

  12 months

Study Arms (1)

PCI and CABG

EXPERIMENTAL

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

Interventions

Coronary artery bypass grafting DEVICE

PCI and CABG

Percutaneous coronary intervention PROCEDURE

PCI and CABG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teikyo University: lead

Related Publications (1)

• Sugimoto K, Takahashi K, Okune M, Ueno M, Fujita T, Doi H, Tobaru T, Takanashi S, Kinoshita Y, Okawa Y, Fuku Y, Komiya T, Tsujita K, Fukui T, Shimokawa T, Watanabe Y, Kozuma K, Sakaguchi G, Nakazawa G. Impact of quantitative flow ratio on graft function in patients undergoing coronary artery bypass grafting. Cardiovasc Interv Ther. 2023 Oct;38(4):406-413. doi: 10.1007/s12928-023-00929-8. Epub 2023 Apr 5.

  PMID: 37017900 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Coronary Artery Bypass; Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures; Endovascular Procedures; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 9, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Last Updated: September 9, 2016

Record last verified: 2016-09