Coronary Artery Disease Clinical Trial
— DUTCHPEERSOfficial 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).
Verified date | February 2017 |
Source | Thorax Centrum Twente |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Rationale:
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.
Objective:
To investigate whether the clinical outcome is similar after implantation of the Promus
Element versus the Resolute Integrity stent (non-inferiority hypothesis).
Study design:
Multicenter, prospective, randomized single-blinded study.
Study population:
Patients who require percutaneous coronary interventions (PCI) for the treatment of coronary
stenoses with an indication for DES use, according to current guidelines and/or the
operators clinical judgement. All clinical syndromes will be included.
Intervention:
In patients who are eligible for DES implantation, the type of DES implanted will be
randomized (Resolute Integrity stent versus Promus Element stent). At the start of the
study, both DES will also be used in routine clinical practice.
Main study endpoints:
The primary endpoint is the incidence of target vessel failure at one year follow-up. Target
vessel failure (TVF) is a composite endpoint consisting of cardiac death, target vessel MI,
or clinically driven target vessel revascularization. Further secondary clinical and
angiographic endpoints will be investigated, defined in accordance with suggestions of the
Academic Research Consortium (ARC). Of note, the angiographic assessment is based on
clinically indicated projections only and results in no additional x-ray exposure. There is
no routine angiographic follow-up. If angiographic data are available in patients who
undergo symptom-driven re-catheterization, we will analyze these data to get insight into
the mechanisms of potential DES restenosis.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: Patients will receive the routine clinical treatment. As a consequence, the
risks of this trial do not exceed the risks of any routine PCI procedure.
Status | Active, not recruiting |
Enrollment | 1811 |
Est. completion date | June 2017 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Minimum age of 18 years; - Coronary artery disease and lesion(s) eligable 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 aspirin, clopidogrel or ticlopidin, heparin, or components of the two DES examined; - Known pregnancy; - Life expectancy of less than 1 year. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Medisch Centrum Alkmaar | Alkmaar | |
Netherlands | Ziekenhuis Rijnstate | Arnhem | |
Netherlands | Scheper Ziekenhuis | Emmen | |
Netherlands | Medisch Spectrum Twente | Enschede |
Lead Sponsor | Collaborator |
---|---|
Thorax Centrum Twente |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Longitudinal stent deformation | Identification of deformation of a stent in the longitudinal axis during coronary angiographic assessment. | 1 year | |
Primary | Target-vessel failure (TVF) | Components of the primary endpoint in hierarchical order: Cardiac death. All deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established; Target vessel related MI that is Q-wave or non-Q-wave myocardial infarction that can be related to the target vessel or cannot be related to another vessel; Clinically driven repeated target vessel revascularization by means of CABG or PCI. |
1 year | |
Secondary | Death at 1 and 2 year follow-up | Death distinguished into: cardiac, vascular, other causes, all-cause mortality | 1 and 2 year | |
Secondary | Myocardial infarction at 1 and 2 year follow-up | Myocardial infarction distinguished into Q-wave and non-Q-wave myocardial infarction | 1 and 2 year | |
Secondary | Revascularization at 1 and 2 year follow-up | Target-vessel revascularization distinguished into PCI or CABG | 1 and 2 year | |
Secondary | Stent thrombosis at 1 and 2 year follow-up | Stent thrombosis was distinguished into definite, probable and possible according to the Academic Research Consortium (ARC) definition. | 1 and 2 year |
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