Primary research questions:* To investigate whether the clinical outcome following the randomized implantation of the Endeavor Resolute® versus XIENCE V® drug-eluting stent is similar, as assessed in a non-inferiority setting by comparing target-…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Target vessel failure (TVF) at 12 months (according to ARC definitions)
Components of the primary endpoint in hierarchical order:
* 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.
* 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.
* Clinically driven repeated target vessel revascularization by means of CABG
or PCI (n,%)
Secondary outcome
• Clinical endpoints at one and three month and 1,2,3,5 year follow-up (with
the exception of TVF at 1 year which is the primary endpoint, as described
above):
o Death
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
o Clinically indicated repeated target vessel revascularization (TVR)
o Clinically indicated repeated target lesion revascularization (TLR)
o New onset of angina pectoris
o Stent thrombosis (Definite, Probable, and Possible; ARC definition):
• Composite endpoint at one month and 1,2,3,5 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
o MACE, device/lesion oriented
• Angiographic endpoints in entire population at final angiographic assessment.
• A substudy will include 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.
• In subgroup of patients with clinically indicated Intravascular ultrasound
(IVUS) endpoints will be assessed
Background summary
At this moment, most interventional cardiologists in Europe consider both, the
Endeavor Resolute stent and the XIENCE V stent as promising second-generation
DES. The current medical literature does not suggest that one of these DES may
be superior to the other. In agreement with the general trend in Europe, the
interventional cardiologists at MST use both of these DES in routine clinical
practice. In fact, the Endeavor Resolute stent and the XIENCE V stent are
already used *at random* at our center.
Instead of unintentionally choosing one of these second-generation DES, we
would like to randomize the use of these two second-generation DES in patients,
who should be stented with DES anyway. This would allow us to obtain valuable
scientific data, which permit a head-to-head comparison of these two DES with
regards to the clinical outcome in a real world scenario. In addition,
efficacy, safety, and acute angiographic results of the implantation of both
stents can be compared. Accordingly, we designed the protocol of the TWENTE
Study - a study which intends to evaluate the clinical outcome of randomized
application of two second-generation drug-eluting stents (Endeavor Resolute
stent vs. XIENCE V stent) in a non-selected population of patients who undergo
PCI with use of DES implantation.
Study objective
Primary research questions:
* To investigate whether the clinical outcome following the randomized
implantation of the Endeavor Resolute® versus XIENCE V® drug-eluting stent is
similar, as assessed in a non-inferiority setting by comparing target-vessel
failure (TVF) of both stents. In brief, we want to compare for both
drug-eluting stents the combined endpoint of death, myocardial infarction or
revascularization related to the target-vessel, as well as death or myocardial
infarction that cannot be related to a significant flow obstruction in another
vessel or to another cause.
Secondary research questions:
* We want to compare the effectivity, safety, clinical short- and long-term
outcome, and the acute angiographic results of the implantation of two
second-generation drug-eluting stents in a real world scenario. Angiographic
comparison will be based on the routine Angiography runs recorded during
routine diagnostic coronary angiography and routine angiography runs during PCI
procedures. No additional angiographic studies are required.
Study design
Randomized study comparing the clinical outcomes of two CE-certified
second-generation drug-eluting stents: the Endeavor Resolute stent and XIENCE V
stent.
Study burden and risks
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.
Haaksbergerstraag 55
7513 ER
NL
Haaksbergerstraag 55
7513 ER
NL
Listed location countries
Age
Inclusion criteria
* Indication for PCI with DES implantation based on NVVC/ESC guidelines and/or clinical decision of interventional cardiologist
* Age >= 18 years and mentally capable to give an informed consent
* Signed informed consent
Exclusion criteria
* Patients with ST-elevation myocardial infarction (STEMI) or an ST-elevation myocardial infarction equivalent requiring primary PCI or rescue PCI
* Patients in whom the revascularization procedure is planed to be performed in a staged approach
* Renal failure requiring haemodialysis
* Patient is currently participating in an investigational drug or device study that has been not completed
* Life expectancy less than 1 year
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22222.044.08 |