OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiO

Not Applicable

• Conditions: Coronary Artery Disease

• Registration Number: JPRN-UMIN000010580
• Lead Sponsor: Translational Research Informatics Center, Foundation for Biomedical Research and Innovation

Brief Summary

Target vessel failure occurred in 21 (5.2%) of 401 patients undergoing OFDI-guided PCI, and 19 (4.9%) of 390 patients undergoing IVUS-guided PCI, demonstrating non-inferiority of OFDI-guided PCI to IVUS-guided PCI (hazard ratio 1.07, upper limit of one-sided 95% confidence interval 1.80; Pnon-inferiority = 0.042).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-24
• Study Completion: 2016-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 829

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with AMI within 3 months 2) Patients with cardiogenic shock 3) Patients with chronic heart failure 4) Patients with renal failure (eGFR <= 30 ml/min/1.73 m2 or Serum creatinine level >=1.5mg/dL) 5) Patients who is currently enrolled other clinical trial which has possibility to influence the primary endpoint of OPINION trial. 6) Patients planned use of bare metal stent 7) 3 vessel diseases 8) Patient who is scheduled to undergo surgical operation within 1 year. 9) Patient on dialysis 10) Target lesion such as: - Left main coronary artery - Aorto-Ostial lesion location within 3mm of the aorta junction - Chronic total occlusion - Small vessel (<2.5mm) - Coronary artery bypass graft - In-stent restenosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of cardiac death, target vessel-related myocardial infarction (MI) and clinically-driven target vessel revascularization(TVR) at 12 months after PCI(Target Vessel Failure:TVF)

Secondary Outcome Measures

Name	Time	Method
Cardiac death, MI, Clinically-driven Target lesion revascularization(TLR), MACE (composite of cardiac death, MI, TLR), TVR, Stroke, Stent thrombosis, Binary restenosis, Renal dysfunction at 12 months after PCI