An observational study in Coronary Artery Disease and Cardiovascular Diseases, sponsored by Medtronic Vascular. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-25.
Sponsored by Medtronic Vascular (part of Medtronic) · Observational
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.
As part of the broader clinical program of the Resolute stent, the RESOLUTE International registry will expand the experience and understanding of the device performance in a 'real-world' setting. The registry intends to enroll patients from a large number of centers under commercial usage conditions, with the aim to reflect 'real-world' usage as much as possible.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 2,349 is above the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Medtronic Vascular is the lead sponsor of 60 studies on the registry; 7 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
All consecutive patients eligible for drug-eluting stent implantation with the elective use of the Endeavor Resolute stent in one or more target lesions are candidates to be enrolled
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Stent implantation
Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel)
Time frame: 12 Months
Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition
Time frame: 12 Months
Start recruitment: August 28, 2008 \> End recruitment: March 19, 2009
| Milestone | Resolute Drug-Eluting Stent |
|---|---|
| Started | 2349 |
| Completed | 2345 |
| Not completed | 4 |
| Withdrew: Withdrawal by subject | 4 |
| percentage of participants | Cardiac Death or Target Vessel MI |
|---|---|
| Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel) | 4.2 |
| percentage of participants | Overall Stent Thrombosis (Definite and Probable-ARC) |
|---|---|
| Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition | 0.9 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Resolute Drug-Eluting Stent | — | 33/2,334 (1.4%) | 0/2,334 (0%) |
| Event | Resolute Drug-Eluting Stent |
|---|---|
| Cardiac DeathCardiac disorders | 33/2334 |
| Age, Categorical(Participants) | Resolute Drug-Eluting Stent |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1260 |
| >=65 years | 1089 |
| Age Continuous(years) | Resolute Drug-Eluting Stent |
|---|---|
| Mean | 63.5 ± 11.2 |
| Sex: Female, Male(Participants) | Resolute Drug-Eluting Stent |
|---|---|
| Female | 521 |
| Male | 1828 |
| Region of Enrollment(participants) | Resolute Drug-Eluting Stent |
|---|---|
| Europe | 2118 |
| India | 174 |
| Argentina | 17 |
| South Africa | 40 |
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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