Evaluation of the Safety & Effectiveness of the PROMUS Element Everolimus-Eluting Coronary Stent System in patients with new or untreated atherosclerotic coronary artery lesions
A Prospective, Multicentre Trial to assess the safety & effectiveness of an Everolimus-Eluting Coronary Stent System (PROMUS Element) for the Treatment of a Single De Novo Coronary Artery Long Lesion (24 - 34mm in length)
Boston Scientific Pty Ltd
102 participants
Aug 21, 2009
Interventional
Conditions
Summary
The PROMUS Element Long Lesion clinical trial –PLATINUM LL, is a prospective, multi-centre trial to evaluate the safety and effectiveness of the PROMUS Element Everolimus-Eluting Coronary Stent System in patients with a lesion that is 24-34mm in length. Treatment will be in participants with a single de novo (new or untreated) atherosclerotic coronary artery lesion. A separate coronary artery (de novo) narrowing is able to be treated with a commercial treatment (eg: stent such as PROMUS, balloon angioplasty, excluding brachytherapy) during the initial procedure. Up to 35 sites enrolling up to 102 patients. Follow up at 30 days, 6 and 12 months after intervention.
Eligibility
Inclusion Criteria9
- Patient is eligible for percutaneous coronary intervention (PCI)
- Patient has documented stable angina
- pectoris, or documented silent ischaemia, or
- unstable angina pectoris
- Patient is acceptable candidate for Coronary Artery Bypass Graft (CABG)
- Patient has left ventricular ejection fraction of >30%
- Target lesion must be de novo and located within native coronary artery with diameter 2.5mm to 4.25mm
- Target lesion must be 24mm to 34mm in length
- Target lesion must be in a major coronaryartery or branch with visually estimated stenosis >50% and <100%
Exclusion Criteria6
- Clinical symptoms or Electrocardiogram (ECG) changes consistent with Myocardial Infarction (MI)
- Patient has known diagnosis of recent MI
- (within 72 hours prior to index procedure) and has elevated enzymes at time of index procedure
- Target vessel or side branch treated with any type of PCI within 12 months prior to index procedure
- Patient is receiving chronic anticoagulation therapy for indications other than acute coronary syndrome
- Females who are pregant, nursing/lactating or planning to procreate within 12 months of the index procedure
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Interventions
The Everolimus-Eluting Coronary Stent System (PROMUS Element) is a metal tube coated with the drug Everolimus. One stent will be permanently implanted in the patient via use of a catheter inserted into the vasculature. The drug dosage depends on the size of the stent and varies from 57 micrograms (2.25x12mm stent) to 242 micrograms (4.0x38mm stent) and this drug is gradually released into the surrounding arterial tissue for approximately 3 months following stent implantation. Stent size is selected by the investigator based on vessel diameter and length. Typically stent diameter is selected to be slightly larger than the vessel diameter (ie a 3.0mm stent would be used to treat a 2.8mm vessel). Typically stent length is selected so that the stent is 2-4mm longer than the lesion length (ie a 28mm stent would be used to treat a 22mm lesion)
Locations(3)
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ACTRN12609000724279