DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population (DUTCH PEERS)

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ClinicalTrials.gov Identifier: NCT01331707

Recruitment Status : Completed

First Posted : April 8, 2011

Last Update Posted : July 28, 2015

Sponsor:

Information provided by (Responsible Party):

prof. C. von Birgelen, Thorax Centrum Twente

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Acute Coronary Syndrome Angina Pectoris Angina, Unstable Myocardial Infarction Coronary Artery Disease Coronary Stenosis Coronary Restenosis	Device: Resolute Integrity (Zotarolimus-eluting stent) Device: Promus Element (Everolimus-eluting stent)	Phase 4

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1811 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	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)
Study Start Date :	November 2010
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2013

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Promus Element	Device: Promus Element (Everolimus-eluting stent) Third generation drug-eluting stent
Active Comparator: Resolute Integrity	Device: Resolute Integrity (Zotarolimus-eluting stent) Third generation drug-eluting stent

Outcome Measures

Primary Outcome Measures :

Target vessel failure (TVF): a composite of Cardiac death, Target vessel related Myocardial Infarction and Clinically driven repeated target vessel revascularization [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Minimum age of 18 years;
Coronary artery disease and lesion(s) eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement;
Patient is willing and able to cooperate with study procedures and required follow-up visits; and patient has been informed and agrees on the participation by signing an EC approved written informed consent.

Exclusion Criteria:

Participation in another randomized drug or device study before reaching primary endpoint;
Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
Intolerance to a P2Y12 receptor antagonist that results in the patient's inability to adhere to dual-antiplatelet therapy, or intolerance to aspirin, heparin, or components of the two DES examined;
Known pregnancy;
Life expectancy of less than 1 year.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331707

Locations


Netherlands
Medisch Centrum Alkmaar
Alkmaar, Netherlands
Hospital Rijnstate
Arnhem, Netherlands
Scheper Hospital
Emmen, Netherlands
Thoraxcentrum Twente
Enschede, Netherlands

Sponsors and Collaborators

Cardio Research Enschede BV

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

van der Heijden LC, Kok MM, Danse PW, Schramm AR, Hartmann M, Löwik MM, Linssen GC, Stoel MG, Doggen CJ, von Birgelen C. Small-vessel treatment with contemporary newer-generation drug-eluting coronary stents in all-comers: Insights from 2-year DUTCH PEERS (TWENTE II) randomized trial. Am Heart J. 2016 Jun;176:28-35. doi: 10.1016/j.ahj.2016.02.020. Epub 2016 Mar 17.

von Birgelen C, Sen H, Lam MK, Danse PW, Jessurun GA, Hautvast RW, van Houwelingen GK, Schramm AR, Gin RM, Louwerenburg JW, de Man FH, Stoel MG, Löwik MM, Linssen GC, Saïd SA, Nienhuis MB, Verhorst PM, Basalus MW, Doggen CJ, Tandjung K. Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial. Lancet. 2014 Feb 1;383(9915):413-23. doi: 10.1016/S0140-6736(13)62037-1. Epub 2013 Oct 31. Erratum in: Lancet. 2014 Feb 1;383(9915):412.

Tandjung K, Basalus MW, Sen H, Jessurun GA, Danse PW, Stoel M, Linssen GC, Derks A, van Loenhout TT, Nienhuis MB, Hautvast RW, von Birgelen C. DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity (DUTCH PEERS): rationale and study design of a randomized multicenter trial in a Dutch all-comers population. Am Heart J. 2012 Apr;163(4):557-62. doi: 10.1016/j.ahj.2012.02.001.


Responsible Party:	prof. C. von Birgelen, Professor C. von Birgelen, Thorax Centrum Twente
ClinicalTrials.gov Identifier:	NCT01331707 History of Changes
Other Study ID Numbers:	DUTCH PEERS NTR2413 ( Registry Identifier: Dutch trial register entry )
First Posted:	April 8, 2011 Key Record Dates
Last Update Posted:	July 28, 2015
Last Verified:	July 2015

Keywords provided by prof. C. von Birgelen, Thorax Centrum Twente:


drug-eluting stent Zotarolimus Everolimus	all comers population target vessel failure coronary artery disease

Additional relevant MeSH terms:


Infarction Coronary Artery Disease Myocardial Ischemia Coronary Disease Myocardial Infarction Acute Coronary Syndrome Angina Pectoris Coronary Stenosis Coronary Restenosis Angina, Unstable Ischemia Pathologic Processes Necrosis Heart Diseases Cardiovascular Diseases	Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Chest Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Everolimus Sirolimus Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents

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