None listed
Conditions
Brief summary
The PROMUS Element small vessel clinical trial – PLATINUM SV, 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 in a smal vessel (2.25-2.5mm diameter). 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 94 patients. Follow up at 30 days, 6 and 12 months after intervention.
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)
Sponsors
Boston Scientific Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is eligible for percutaneous coronary intervention (PCI) 2. Patient has documented stable angina pectoris, or documented silent ischaemia, or unstable angina pectoris 3. Patient is acceptable candidate for Coronary Artery Bypass Graft (CABG) 4. Patient has left ventricular ejection fraction of >30% 5. Target lesion must be de novo and located within native coronary artery with diameter 2.25mm to 2.50mm 6. Target lesion must be <28mm in length 7. Target lesion must be in a major coronary artery or branch with visually estimated stenosis >50% and <100%
Exclusion criteria
1. Clinical symptoms or Electrocardiogram (ECG) changes consistent with Myocardial Infarction (MI) 2. Patient has known diagnosis of recent MI (within 72 hours prior to index procedure) and has elevated enzymes at time of index procedure 3. Target vessel or side branch treated with any type of PCI within 12 months prior to index procedure 4. Patient is receiving chronic anticoagulation therapy for indications other than acute coronary syndrome 5. Females who are pregnant, nursing/lactating or planning to procreate within 12 months of the index procedure
Outcome results
None listed