Clinical safety evaluation of Endeavor stent in octogenerians.
- Conditions
- Coronary artery disease
- Registration Number
- JPRN-UMIN000004138
- Lead Sponsor
- Cardiovascular center, Shinkawabashi hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Not provided
1)Limited Life expectancy within 12months. 2)Inability to comply with the required IFU antiplatelet regimen. 3)Ejection Fraction<30%. 4)Unprotected LMT disease. 5)Chronic Total Occulution. 6)The lesions in all native coronary arteries, LCX/LAD/RCA should be amenable to PCI. 7)Severe valvular disease. 8)Renal Failure. 9)Taking Warfarin Potassium. 10)Planed PCI of any vessel within 30 days post-index procedure and/or planed PCI of the target vessel(s) within 12 months post-procedure. 11)Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel and ticlopidine, cobalt, nickel, chromium, molybdenum, polymer coating (e.g.PC polymer) or a sensitivity to contrast media, which cannot be adequately pre-medicated. 12)Acute myocardial infaction with cardogenic shock. 13)Previous stenting in the target vessel(s). 14)Prior to enrollment in this study, if a surgical or any procedure is anticipated that would require early discontinuation of 3-month antiplatelet therapy. 15)Patient is not an acceptable candidate for PCI at a physician's discretion.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MACCE (Death, myocardial infarction, cerebrovascular accident, target lesion revascularization, target vessel revascularization)
- Secondary Outcome Measures
Name Time Method The occurence of bleeding complications, stent thrombosis, the duration of dual antiplatelet agents.