Thailand Orsiro Registry: Safety and Performance Registry for an all-comers patient population with the Limus Eluting Orsiro Stent System within daily clinical practice
- Conditions
- all-comers patient population with the Limus Eluting Orsiro Stent System within daily clinical practiceStent
- Registration Number
- TCTR20180828006
- Lead Sponsor
- Catheterization laboratory
- Brief Summary
The safety and efficacy of the ultrathin strut sirolimus-eluting stent in unselected cases are confirmed in Thailand Orsiro registry. Despite the high proportion of pre-specified high-risk subgroup, the excellent stent performance was consistent with the overall population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
Symptomatic coronary artery disease
Subject signed informed consent for data release
Subject is willing to participate at all follow up
assessments
Subject is 21 years of age
Exclusion Criteria
Subject did not sign informed consent for data
release
Known intolerance to aspirin, clopidogrel, ticlopidine,
heparin or any other anticoagulation / antiplatelet
therapy required for PCI, stainless steel, Sirolimus or
contrast media
Planned surgery within 6 months of PCI unless dual
antiplatelet therapy will be maintained
Pregnancy
Currently participating in another study and primary
endpoint is not reached yet.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Target Lesion Failure (TLF) at 12 months Composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction (MI), Emergent
- Secondary Outcome Measures
Name Time Method Target Lesion Failure (TLF) at 6 months 6 months follow up (FUP)