CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,514 enrolled
Drug / intervention
Orsiro +2 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/NCT01674803
NCT01674803N/ACompleted

Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion: Randomized Multicenter Trial in an All Comers Population Treated Within thE NeThErlands 3 (TWENTE 3)

Foundation of Cardiovascular Research and Education Enschede·interventional·Posted Aug 29, 2012·Updated Jul 20, 2022

In Brief

A clinical study evaluating Orsiro, Synergy, and 1 other intervention for Acute Coronary Syndrome and 6 related conditions. Completed, enrolled 3,514 participants across 1 site.

Detailed Summary

The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with biodegradable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such biodegradable polymer DES are increasingly used in clinical practice, there is no data available from head-to-head comparisons between biodegradable and contemporary third generation durable polymer DES.

Study Details

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

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 29, 2012
Enrollment StartDec 21, 2012
Primary CompletionAug 24, 2016
Study CompletionAug 25, 2020
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 13.8 years ago

Interventions

Orsirodevice

biodegradable polymer sirolimus eluting stent

Synergydevice

biodegradable polymer everolimus eluting stent

Resolute Integritydevice

durable polymer zotarolimus-eluting stent