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 |
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Recruitment Status :
Completed
First Posted : April 8, 2011
Last Update Posted : July 28, 2015
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Sponsor:
Foundation of Cardiovascular Research and Education Enschede
Information provided by (Responsible Party):
prof. C. von Birgelen, Thorax Centrum Twente
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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 |
| Actual Primary Completion Date : | December 2012 |
| Actual Study Completion Date : | December 2013 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Everolimus
| 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 :
- 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, Older Adult) |
| 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.
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
Foundation of Cardiovascular Research and Education Enschede
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 |
| 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:
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drug-eluting stent Zotarolimus Everolimus |
all comers population target vessel failure coronary artery disease |
Additional relevant MeSH terms:
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Coronary Artery Disease Myocardial Ischemia Coronary Disease Myocardial Infarction Acute Coronary Syndrome Angina Pectoris Coronary Stenosis Coronary Restenosis Angina, Unstable Infarction Ischemia Pathologic Processes Necrosis |
Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Chest Pain Pain Neurologic Manifestations Everolimus Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |