CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,811 enrolled
Drug / intervention
Resolute Integrity (Zotarolimus-eluting stent) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01331707
NCT01331707Phase 4Completed

DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity (DUTCH PEERS): Randomized Multicenter Trial in All Comers Population Treated Within Eastern NeThErlands-2 (TWENTE-2)

Foundation of Cardiovascular Research and Education Enschede·interventional·Posted Apr 8, 2011·Updated Jul 28, 2015

In Brief

A Phase 4 clinical trial evaluating Resolute Integrity (Zotarolimus-eluting stent) and Promus Element (Everolimus-eluting stent) for Acute Coronary Syndrome and 6 related conditions. Completed, enrolled 1,811 participants across 4 sites.

Detailed Summary

The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity but there are further demands on DES performance. Such demands are an optimized performance in very challenging coronary lesions; third generation DES were developed in an effort to further improve DES performance in such challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus Element stents) are currently available; there are no data that indicate an advantage of one of these DES over the other.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 8, 2011
Enrollment StartNov 1, 2010
Primary CompletionDec 1, 2012
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.2 years ago

Interventions

Resolute Integrity (Zotarolimus-eluting stent)device

Third generation drug-eluting stent

Promus Element (Everolimus-eluting stent)device

Third generation drug-eluting stent