To investigate whether the clinical outcome is similar after the implantation of the Resolute Integrity stent versus the Promus Element stent (non-inferiority test).
ID
Bron
Verkorte titel
Aandoening
Percutaneous Coronary Intervention (PCI)
Drug-eluting stent
Coronary atherosclerosis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Main study parameter/endpoint:<br>
Target vessel failure (TVF) at 12 months (according to ARC definitions).
<br><br>
Components of the primary endpoint in hierarchical order:<br>
1. Cardiac death. All deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established;<br>
2. 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;<br>
3. Clinically driven repeated target vessel revascularization by means of CABG or PCI.
Achtergrond van het onderzoek
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:
Multi-center, 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.
Doel van het onderzoek
To investigate whether the clinical outcome is similar after the implantation of the Resolute Integrity stent versus the Promus Element stent (non-inferiority test).
Onderzoeksopzet
Baseline, 1 month, 1 year, 2 years.
Onderzoeksproduct en/of interventie
Intervention will involve randomization of the type of DES (Promus Element versus Resolute Integrity) used in study population. Duration of randomization will be two years.
Publiek
Haaksbergerstraat 55
H. Verheij
Enschede 7513 ER
The Netherlands
+31 (0)53 4872105
h.verheij@ziekenhuis-mst.nl
Wetenschappelijk
Haaksbergerstraat 55
H. Verheij
Enschede 7513 ER
The Netherlands
+31 (0)53 4872105
h.verheij@ziekenhuis-mst.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Minimum age of 18 years;
2. Coronary artery disease and lesion(s) eligable for treatment with drug eluting stents according to clinical guidelines and/or the operators’ judgement;
3. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Participation in another randomized drug or device study before reaching primary endpoint;
2. Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
3. 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;
4. Known pregnancy;
5. Life expectancy of less than 1 year.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL2307 |
NTR-old | NTR2413 |
Ander register | METC MST : p10-29 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |