N/A
Completed N=318
Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent
Coronary Arteriosclerosis
Source: ClinicalTrials.gov NCT00968019 ↗
Enrolled (actual)
318
Serious AEs
12.3%
Results posted
Mar 2013
Primary outcomePrimary: Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization)) — 9 participants
Summary
The purpose of this study is: To evaluate the safety and performance of the Presillion stent in routine clinical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization)) |
9 | — |
| SECONDARY Device Success |
98.9 | — |
| SECONDARY Lesion Success |
98.6 | — |
| SECONDARY Procedural Success |
97.2 | — |
| SECONDARY Clinically Driven TLR |
5 | — |
| SECONDARY Clinically Driven TVR |
5 | — |
| SECONDARY Target Vessel Failure |
11 | — |
| SECONDARY Myocardial Infarction |
8 | — |
| SECONDARY Major Bleeding |
— | — |
| SECONDARY Stroke |
— | — |
| SECONDARY Stent Thrombosis |
2 | — |
Eligibility Criteria
Inclusion Criteria
- All subjects treated with Presillion stent up to two de novo coronary artery lesions
Exclusion Criteria
- No specified
Data sourced from ClinicalTrials.gov (NCT00968019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.