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 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:
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 ]
| 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) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 |
| Study First Received: | March 30, 2011 |
| Last Updated: | July 27, 2015 |
| 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:
|
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 September 27, 2016