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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:
Cardio Research Enschede BV
Information provided by (Responsible Party):
prof. C. von Birgelen, Thorax Centrum Twente
ClinicalTrials.gov Identifier:
NCT01331707
First received: March 30, 2011
Last updated: July 27, 2015
Last verified: July 2015
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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 Blind (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| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01331707
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
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 ) |
| Study First Received: | March 30, 2011 |
| Last Updated: | July 27, 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 |
ClinicalTrials.gov processed this record on August 16, 2017