Multicenter Prospective Randomized Study of First-choice Guidewires in Percutaneous Coronary Intervention for Chronic Total Occlusio
Phase 4
- Conditions
- Patients undergoing Percutaneous Coronary Intervention (PCI) for chronic total occlusion (CTO)
- Registration Number
- JPRN-UMIN000002573
- Lead Sponsor
- Tokai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 290
Inclusion Criteria
Not provided
Exclusion Criteria
Patients for whom PCI is not indicated Patients with the same CTO previously treated with PCI without success Patients with restenosis or in-stent restenosis Patients with a venous or arterial graft Patients under 21 years old Women of child-bearing potential Patients who do not provide informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method esion penetration rate of a first-choice guidewire
- Secondary Outcome Measures
Name Time Method Successful PCI rate Definition of successful PCI: The target lesion is successfully dilated without any major cardiovascular events. Types of guidewires successfully passing through the lesion Usage rate and success rate of the retrograde approach Usage rate and success rate of the parallel wire technique Usage rate and success rate of IVUS assistance Usage rate and success rate of coronary CT Total death Cardiac death Myocardial infarction (MI) (Q-wave/non-Q-wave) Emergency surgeries (CABG/other) Major adverse cardio-cerebral events (MACCEs: total death, MI, stroke, and all revascularization procedures) Stroke Guidewire-induced perforation Cardiac tamponade Hemorrhagic complications Puncture site complications Sizes and types of guiding catheters Approach sites Total number of guidewires used Total number of guiding catheters used Total number of CTO treated cases during the enrollment period