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Comparison between Optimal Coherence tomography guidance and Angiography Guidance in percutaneous coronary interventio

Phase 4
Conditions
Ischemic Heart Disease,percutaneous coronary intervention
Registration Number
JPRN-UMIN000026021
Lead Sponsor
Wakayama Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
550
Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with ST elevation myocardial infarction(STEMI) 2) Hemodynamic supplements or vasopressors with cardiogenic shock (defined as persistent hypotension with systolic blood pressure <90mm/Hg persisting for more than 30 minutes) or pressure rising/intra-aortic balloon pumping at the time of the procedure Required patient 3) Heart failure patients 4) Patients with three branches disease 5) Patients planned to use bare metal stent (BMS) 6) Patients with renal dysfunction (eGFR 30ml/min/1.73m2 or less or serum creatinine 1.5mg/dl or more) 7) Patients during dialysis treatment 8) Patients who are known to have allergies to aspirin, clopidogrel, prasugrel, heparin, iodine contrast medium, 9) Patients with hemorrhagic complications such as intracranial hemorrhage and gastrointestinal bleeding 10) Patients planning surgical treatment with in 12month after PCI 11) Patients with one or more co-morbidities that shorten life expectancy to less than 12 months or that may interfere with the study process according to this study protocol 12) Patients participating in clinical trials of other medical devices and drugs and judged by the attending physician as affecting the main endpoint of this study 13) Patients scheduled to use IVUS for the PCI to be tested 14) Patients whose treatment subject lesion morphology falls under any of the following

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Minimum Stent Area (MSA) after PCI implementation by OCT evaluation
Secondary Outcome Measures
NameTimeMethod
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