N/A
N=2,349
RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population
Coronary Artery Disease · Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00752128 ↗Enrolled (actual)
2,349
Serious AEs
1.4%
Results posted
Dec 2011
Primary outcome: Primary: Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel) — 4.2 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Endeavor Resolute Zotarolimus-Eluting Coronary Stent System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Vascular
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel) |
4.2 | — |
| SECONDARY Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition |
0.9 | — |
Summary
The primary objective of the RESOLUTE international registry is to document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a 'real-world' patient population requiring stent implantation.
Eligibility Criteria
Inclusion Criteria
- Minimum legal age (18)
- Acceptable candidate for treatment with a drug-eluting stent in accordance with applicable guidelines
- Patient has consented to participate and authorized in writing the collection and release of medical information
- Elective use of the Endeavor Resolute stent
Exclusion Criteria
- Pregnancy
- High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- Currently participating in another trial preventing routine hospital treatment
- Previous enrollment in the RESOLUTE International registry
Data sourced from ClinicalTrials.gov (NCT00752128). 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.