To determine the safety and effectiveness of Boston Scientific*s Everolimus-eluting coronary stent system (PROMUS Element*) for coronary revascularization in an unrestricted population compared to the Xience* Prime control.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Target Vessel failure (TVF) of the PROMUS Element* Everolimus-Eluting Coronary
Stent at 12 months post-procedure. TVF is defined as any ischemia-driven
revascularization of the target Vessel (TVR), MI (Q-wave and non-Q-wave)
related to the target vessel, or cardiac death related to the target vessel.
Secondary outcome
Secondary Endpoints:
Clinical endpoints will be measured at 30 days, 12 months and 2 years, and :
* Ischemia Driven Target Lesion Revascularization (TLR) rate
* Ischemia Driven Target Vessel Revascularization (TVR) rate
* Target Lesion Failure (TLF) rate: defined as any ischemia-driven
revascularization of the target lesion (TLR), MI (Q-wave and non-Q-wave)
related to the target vessel, or cardiac death related to the target vessel
* Myocardial Infarction (MI) rate: Q-wave and non-Q-wave, cumulative and
individual
* Cardiac death rate
* Non-cardiac death rate
* All death or MI rate
* All Death/MI/TVR rate
* Major Adverse Cardiac Event (MACE) rate defined as a composite of death, MI
(Q wave or non-Q wave), emergent coronary artery bypass surgery (CABG), or
target lesion revascularization (TLR) by repeat PTCA or CABG.
* Stent Thrombosis (ST) rate using ARC definition of definite and probable
stent thrombosis and categorized as early, late or very late.
Procedural Endpoints:
* Device success, defined as attainment of <30% residual stenosis of the target
lesion (visual assessment) using the PROMUS Element* or Xience* Prime stent.
* Lesion success defined as attainment of < 30% residual stenosis (visual
assessment) using any percutaneous method.
* Procedure success defined as lesion success without the occurrence of
in-hospital MACE.
* Procedure complication rate including composite and individual angiographic
occurrence of dissection >B, distal embolization, no reflow, slow flow, abrupt
closure, or perforation.
Background summary
The PLATINUM-PLUS trial will investigate in a broad patient and lesion
population, the CE Mark approved PROMUS Element* Everolimus-Eluting Coronary
Stent System (PROMUS Element), which combines the Element* stent (the latest
generation stent from Boston Scientific Corporation [BSC, Natick,
Massachusetts, United States]), everolimus, and the poly (n-butyl methacrylate)
(PBMA) and poly (vinylidene fluoride-co-hexafluoropropylene) (PVDF-HFP)
polymers. The PROMUS Element, received CE Mark on November 3rd 2009; it is
currently under investigation in the PLATINUM clinical trial, and has great
promise as it combines BSC*s novel stent technology with the everolimus drug
and polymers that have demonstrated excellent performance in the SPIRIT
clinical program.
Study objective
To determine the safety and effectiveness of Boston Scientific*s
Everolimus-eluting coronary stent system (PROMUS Element*) for coronary
revascularization in an unrestricted population compared to the Xience* Prime
control.
Study design
The PROMUS Element* clinical trial (PLATINUM-PLUS) consists of a randomized
controlled trial (RCT) in the European Union (EU) and Switzerland which will
enroll approximately 2980 subjects (2:1 randomization PROMUS Element*: Xience*
Prime) in a Population of consecutive, all comers in the reimbursed indications
per-country. All subjects will be screened per the protocol required
inclusion/exclusion criteria.
Intervention
2:1 randomization for treatment with PROMUS Element* Everolimus-Eluting
Coronary Stent or treatment with Xience* Prime Everolimus-Eluting Coronary
Stent
Study burden and risks
No extra risks are associated with partaking in this study when compared to
standard treatment.
There is a marginal additional burden due to the follow-up, however every
effort is made to combine this follow-up with regular controls.
No additional benefits are expected from partaking in this study except of
course a possible improvement in the treatment of future new disease.
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Listed location countries
Age
Inclusion criteria
1. The patient must be >=18 of age
2. Symptomatic ischemic heart disease (CCS class 1-4, Braunwald Class IB, IC, and/or objective evidence of myocardial ischemia);
3. Acceptable candidate for CABG;
4. The patient is willing to comply with specified follow-up evaluations;
5. The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC).
6. Single or multiple native coronary artery or saphenous vein graft lesions in single or multiple vessels;
7. Patients with multi-lesion or multi-vessel coronary disease may undergo staged (planned) procedures within 42-days of the index procedure.
8. Reference vessel diameter must be >=2.25 to <= 4.25 mm by visual estimate.
Exclusion criteria
1. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test;
2. Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated;
3. Patient has other medical illness (e.g., cancer, known malignancy , congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
4. Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, platinum chromium alloy, everolimus, and/or contrast sensitivity that cannot be adequately pre-medicated;
5. Patient with LVEF <20%, cardiogenic shock, or hemodynamic compromise requiring pressors or inotropes or mechanical support devices
6. Any significant medical condition which in the Investigator*s opinion may interfere with the patient*s optimal participation in the study;
7. Currently participating in another investigational drug or device study.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| ClinicalTrials.gov | NCT01342822 |
| CCMO | NL38465.101.11 |