DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population (DUTCH PEERS)
![]() |
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. |
ClinicalTrials.gov Identifier: NCT01331707 |
Recruitment Status :
Completed
First Posted : April 8, 2011
Last Update Posted : July 28, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |

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 |
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Netherlands | |
Medisch Centrum Alkmaar | |
Alkmaar, Netherlands | |
Hospital Rijnstate | |
Arnhem, Netherlands | |
Scheper Hospital | |
Emmen, Netherlands | |
Thoraxcentrum Twente | |
Enschede, Netherlands |
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 |
drug-eluting stent Zotarolimus Everolimus |
all comers population target vessel failure coronary artery disease |
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 |