The Real-World Endeavor Resolute versus XIENCE V Drug-Eluting SteNt Study in TwentE|
|- candidate number||3141|
|- NTR Number||NTR1256|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-mrt-2008|
|- Secondary IDs||MST/Twente/001 |
|- Public Title||The Real-World Endeavor Resolute versus XIENCE V Drug-Eluting SteNt Study in TwentE|
|- Scientific Title||The Real-World Endeavor Resolute versus XIENCE V Drug-Eluting SteNt Study in TwentE
|- hypothesis||To investigate whether the clinical outcome is similar after the implantation of the Endeavor Resolute stent versus the XIENCE V stent (non-inferiority test).|
|- Healt Condition(s) or Problem(s) studied||Percutaneous Coronary Intervention (PCI), Drug-eluting stent, Coronary atherosclerosis|
|- Inclusion criteria||1. Indication for PCI with DES implantation based on NVVC/ESC guidelines and/or clinical decision of interventional cardiologist |
2. Age ≥ 18 years and mentally capable to give an informed consent
3. Signed informed consent
|- Exclusion criteria||1. Patients with ST-elevation myocardial infarction (STEMI) or an ST-elevation myocardial infarction equivalent requiring primary PCI or rescue PCI|
2. Patients in whom the revascularization procedure is planned to be performed in a staged approach
3. Renal failure requiring haemodialysis
4. Patient is currently participating in an investigational drug or device study that has been not completed
5. In the investigators opinion patient has a co-morbid condition(s) that could limit the patient’s ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
6. Life expectancy less than 1 year
7. Patients in whom during PCI there is no indication for DES use and/or if the operator chooses not to use a DES based on the clinical situation, the patient will be excluded
8. When the choice of DES is dictated by logistic reasons e.g. the required DES dimensions is provided by one manufacturer only and not by the other.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2008|
|- planned closingdate||31-dec-2011|
|- Target number of participants||1380|
|- Interventions||Intervention will involve randomization of the type of DES ( Endeavor Resolute vs XIENCE V) used in study population. Duration of randomization will be two years.|
|- Primary outcome||Main study parameter/endpoint:|
• Target vessel failure (TVF) at 12 months (according to ARC definitions)
Components of the primary endpoint in hierarchical order:
o Target vessel related death or cardiac death that cannot be clearly attributed to a vessel other than the target vessel. All deaths are considered cardiac, unless an unequivocal noncardiac cause can be established.
o Target vessel related MI (n,%), 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.
o Clinically driven repeated target vessel revascularization by means of CABG or PCI (n,%)
|- Secondary outcome||• Clinical endpoints at one and three month and 1 and 2 year follow-up (with the exception of TVF at 1 year which is the primary endpoint, as described above):|
o Any myocardial infarction:
o Any revascularisation by means of PCI or Coronary Artery Bypass Grafting (CABG).
o Target vessel related death
o Target vessel related myocardial infarction (MI) (n,%):
Q-wave myocardial infarction
Non Q-wave myocardial infarction
o Clinically indicated repeated target vessel revascularization (TVR):
o Clinically indicated repeated target lesion revascularization (TLR):
oNew onset of angina pectoris:
Related to the target vessel.
Related to another vessel.
oStent thrombosis (Definite, Probable, and Possible; ARC definition):
• Composite endpoint at one and three month and 1 and 2 year follow-up (except TVF at one year follow-up which is already the primary endpoint):
o Target vessel failure (TVF) as defined above.
o Major Adverse Cardiac Events (MACE), patient oriented ( hierarchical order):
All cause mortality.
Any MI (including nontarget vessel territory)
Any repeat revascularization (target and nontarget vessels) by means of CABG or PCI
o MACE, device/lesion oriented ( hierarchical order):
MI not clearly attributable to a nontarget vessel
Target lesion revascularization (TLR)
• Angiographic endpoints in entire population at final angiographic assessment :
o At final angiographic assessment the stented segment will be subdivided into 3 equally sized subsegments in which the individual minimum lumen diameter (MLD), reference diameter, percent diameter stenosis (% DS), mean lumen diameter will be determined. The ratio of the MLD to the predicted maximum balloon diameter, as determined from balloon charts provided by the manufacturer, will be calculated as a measure of radial force and potential immediate recoil of the stent. Angiographic endpoints will be assessed in the routine runes recorded during index PCI. The analysis requires no additional angiography runs.
• A substudy will include the following angiographic endpoints in subpopulation of patients referred for angiographic re-evaluation and in subpopulation of these patients who will require re-intervention e.g. clinically indicated angiographic re-evaluation:
o Intra-stent Late Lumen Loss (LLL) measured by QCA and defined as the difference between post-procedure minimal lumen diameter (MLD) and the subsequent angiography. (segment analysis)
o MLD, reference diameter, and %DS ( percent diameter stenosis; segment analysis)
o Angiographic evidence of stent thrombosis as outlined in table 7 of the appendix
• In subgroup of patients with clinically indicated Intravascular ultrasound (IVUS) the following endpoints will be assessed:
o In a subgroup of the patients with clinically indicated IVUS guidance of PCI, both conventional greyscale IVUS and virtual histology IVUS data sets will be analyzed from the IVUS runs that may be acquired before PCI, after the stent implantation, and finally at the end of the PCI procedure. These analyses will include measurements of minimal lumen cross-sectional area (CSA) and diameter, mean lumen CSA, adequacy of stent expansion, stent symmetry, adequacy of stent apposition, plaque prolapse, and stent-reference lumen area ratio .
o In the subgroup of patients with re-PCI for restenosis, the use of IVUS should be considered [18,19], which can help to adequately treat patients. In patients with stent thrombosis, the use of IVUS is strongly recommended, as it may be of critical importance in order to identify the mechanism of stent thrombosis and avoid recurrence of this adverse event. IVUS measurements will include the same as described above in the context of the index procedure with the addition of: measurement of mean neointima, lumen, and stent CSA and volume; in-stent percent volume obstruction; minimum and maximum neointima, lumen, and stent CSA, and minimum and maximum in-stent CSA obstruction; neointima, lumen and stent CSA at the site of the minimum in-stent lumen CSA; and the presence and the extent of late stent malapposition.
|- Timepoints||Baseline, 1 month, 3 months, 1 year, 2 year|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. H. Verheij|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. C. Birgelen, von|
|- Sponsor/Initiator ||Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|Stichting Hartcentrum Twente|
|- Brief summary||Rationale: The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to significant reduction in morbidity but not in mortality. |
Second generation DES were developed in an effort to further decrease morbidity and also to decrease mortality.
In our center, two CE-certified second generation DES (Endeavor Resolute stent and XIENCE V stent) are now used in daily clinical routine. There are no data that indicate an advantage of one of these DES over the other (e.g., for certain indications); therefore, we currently make our choice of DES simply by chance.
Objective: To investigate whether the clinical outcome is similar after the implantation of the Endeavor Resolute stent versus the XIENCE V stent (non-inferiority test).
Study design: Single center prospective randomized single-blinded study.
Study population: Patients who require percutaneous coronary intervention (PCI) for the treatment of coronary stenoses with indication for DES use, according to current guidelines and/or the operators clinical judgement. All clinical syndromes will be included with the exception of ST –elevation myocardial infarction.
Intervention: In patients who will receive a DES anyway, we will randomize the type of DES implanted (Endeavor Resolute stent vs. XIENCE V stent). Both DES are already used in our routine PCI procedures. At this time, no data are available that may suggest the superiority of one of the above-mentioned DES over the other.
Main study endpoints: The primary endpoint is the incidence of target vessel failure at one year follow-up. Target vessel failure (TVF) is any target vessel revascularization, death, or MI which is attributable to the target vessel or not attributable to another vessel. Further secondary clinical and angiographic endpoints will be investigated and have been defined in accordance with the consensus paper of the Academic Research Consortium (ARC) as published in 2007. 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. However, 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 restenosis. In addition, we will analyze clinical intravascular ultrasound (IVUS) images that may be available in a subpopulation of patients (in whom the operator for clinical reasons decides to use IVUS guidance). Of note, there will be no additional IVUS examinations (i.e., no IVUS examination for research purpose only) for this study, but we will analyze the IVUS data from clinical routine where they are available.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will receive the routine treatment provided in our center. As a consequence, the risks of this trial do not exceed the risks of any routine PCI procedure at Medisch Spectrum Twente, because the PCIs in this study will not deviate in any way from the local clinical routine.
|- Main changes (audit trail)|
|- RECORD||26-mrt-2008 - 11-jun-2008|
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