This multicenter, prospective, observational registry will evaluate the safety and performance of the CYPHER SELECT Sirolimus-eluting Coronary Stent, and of all future generation of commercially approved Cordis Sirolimus-eluting Stents (SES), in routine clinical practice.
Phase 4
Completed
- Registration Number
- CTRI/2008/091/000170
- Lead Sponsor
- Johnson and Johnson
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
This registry will be limited to subjects who have received only the CYPHER SELECT. Sirolimus-eluting Coronary Stent during the index procedure; Males and females; no inclusion or exclusion criteria have been specified, uniform, complete and accurate data will be collected peri-procedurally, during the index hospitalization, and during follow-up.
Exclusion Criteria
None
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method acute, sub-acute and late stent thrombosis; Major Adverse Cardiac Events (MACE)Timepoint: Time Frame: 1, 6, 12, 24 and 36 months
- Secondary Outcome Measures
Name Time Method Additional analyses will be performed in patient sub-populations, such as diabetes, in-stent restenosis (ISR), acute myocardial infarction (AMI) and multivessel coronary disease.Timepoint: Subjects will be followed at 1, 6, 12, 24 and 36 months