Clinical outcome of patients with calcified nodule detected by Optical coherence tomography after percutaneous coronary interventio
Not Applicable
- Conditions
- coronary calcified nodule
- Registration Number
- JPRN-UMIN000050297
- Lead Sponsor
- Kobe University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Not provided
Exclusion Criteria
1) patients with life expectancy < 1 year 2) patients with shock status 3) patients with in-stent restenosis or stent thrombosis 4) patients with pregnancy 5) Patients deemed inappropriate for inclusion by the principal investigator or subinvestigator
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient-oriented Composite Endpoint (PoCE) at 12 months after PCI: composite endpoint of all cause death, myocardial infarction and any revascularization Target lesion failure (TLF) at 12 months after PCI: composite endpoint of cardiac death, target vessel-related MI and clinically driven target lesion revascularization (TLR)
- Secondary Outcome Measures
Name Time Method At 12 months after PCI 1) The components of primary outcomes 2) Stent thrombosis 3) Stroke 4) Bleeding event 5) Time to occurrence of each of the primary outcomes At 24 months after PCI 6) The composite endpoint of PoCE 7) The composite endpoint of TLF 8) The components of primary outcomes 9) Stent thrombosis 10) Stroke 11) Bleeding event 12) repeated TLR 13) Time to occurrence of each of the primary outcomes