Primary research questions To investigate whether the outcome after the randomized implantation of the Resolute Integrity® versus Promus Element® drug-eluting stent are similar, as assessed in a non-inferiority setting by comparing target-vessel…
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
Components of the primary endpoint in hierarchical order:
o Cardiac death. All deaths are considered cardiac, unless an unequivocal
non-cardiac cause can be established.
o 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.
o Clinically driven repeated target vessel revascularization by means of CABG
or PCI
Secondary outcome
* Clinical endpoints at 1,12, 24,36,48,60 month 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 (MI)
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 and three month and 12, 24,36,48,60 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 Target Lesion Failure (TLF)
o Major Adverse Cardiac Events (MACE), patient oriented compositie endpoint
(hierarchical order)
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
* In subgroups of patients with clinically indicated Intravascular ultrasound
(IVUS) and/or Optical Coherence Tomography (OCT) endpointswill be assessed
Background summary
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 lesion. Third generation DES were developed in an
effort to further improve DES performance in challenging lesions. Two
CE-certified third generation DES (Resolute Integrity and Promus Element stent)
are currently available; there are no data that indicate an advantage of one of
these DES over the other.
Study objective
Primary research questions
To investigate whether the outcome after the randomized implantation of the
Resolute Integrity® versus Promus Element® drug-eluting stent are similar, as
assessed in a non-inferiority setting by comparing target-vessel failure (TVF)
of both stents at one year follow-up post stent implantation. In brief, we want
to compare for both drug-eluting stents the combined endpoint of (1) cardiac
death, (2) myocardial infarction that can be related to the target vessel or
cannot be related to another vessel, and (3) clinically indicated
revascularization related to the target-vessel. Based on the results of the
RESOLUTE all-comers trial (the study stents in the RESOLUTE all comers trial
used the same coatings and drugs used in the current trial but on different
bare metal stent platforms), non-inferiority of Resolute Integrity® and Promus
Element® is expected. This is not tested in a controlled randomized trial yet.
Secondary research questions
Effectivity, safety, clinical short- and long-term outcome, and the acute
angiographic results of the implantation of two third-generation drug-eluting
stents will be compared in a *real world*, all-comers scenario. Angiographic
comparison will be based on the routine coronary angiography runs recorded
during diagnostic coronary angiography and PCI procedures. No additional
mandatory angiographic studies after the index PCI are required.
Study design
Multi-center, prospective, randomized single-blinded study comparing the
clinical outcomes of two CE certified 3rd generation drug eluting stent:
Resolute Integrity and Promus Element.
Study burden and risks
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.
Haaksbergerstraat 55
Enschede 7513 ER
NL
Haaksbergerstraat 55
Enschede 7513 ER
NL
Listed location countries
Age
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 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
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 |
|---|---|
| Other | Nederlands trial register: NTR2413 |
| CCMO | NL33169.044.10 |