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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
Information provided by (Responsible Party):
prof. C. von Birgelen, Thorax Centrum Twente

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 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
Primary Completion Date : December 2012
Study Completion Date : December 2013

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

Primary Outcome Measures :
  1. 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 ]

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

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.

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

Medisch Centrum Alkmaar
Alkmaar, Netherlands
Hospital Rijnstate
Arnhem, Netherlands
Scheper Hospital
Emmen, Netherlands
Thoraxcentrum Twente
Enschede, Netherlands
Sponsors and Collaborators
Cardio Research Enschede BV

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
all comers population
target vessel failure
coronary artery disease

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