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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01331707
First Posted: April 8, 2011
Last Update Posted: July 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
prof. C. von Birgelen, Thorax Centrum Twente
  Purpose
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 Intervention 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
Study Design: 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)

Further study details as provided by prof. C. von Birgelen, Thorax Centrum Twente:

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 ]

Enrollment: 1811
Study Start Date: November 2010
Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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):
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 Submitted: March 30, 2011
First Posted: April 8, 2011
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