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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
prof. C. von Birgelen, Thorax Centrum Twente
ClinicalTrials.gov Identifier:
NCT01331707
First received: March 30, 2011
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cardio Research Enschede BV:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1788
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Cardio Research Enschede BV

Additional 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
Study First Received: March 30, 2011
Last Updated: July 25, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Cardio Research Enschede BV:
drug-eluting stent
Zotarolimus
Everolimus
 all comers population
target vessel failure
coronary artery disease

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Myocardial Infarction
Coronary Stenosis
Acute Coronary Syndrome
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
 Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Ischemia
Pathologic Processes
Necrosis
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013