None listed
Conditions
Brief summary
The PROMUS Element clinical trial – PLATINUM, is a prospective, multi-centre trial to evaluate the safety and effectiveness of the PROMUS Element Everolimus-Eluting Coronary Stent System compared with the PROMUS Everolimus-Eluting Coronary Stent System. Treatment will be in participants with up to 2 de novo (new or untreated) atherosclerotic coronary artery lesions. 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 160 sites enrolling up to 1,532 patients. Follow up at hospital clinics 30 days, 6 and 12 months. Participants enrolled who did not receive the PROMUS Element or the PROMUS stent will complete follow up at this point. The Primary Endpoint is Target Lesion Failure at 12 months defined as ischaemia-driven Target Lesion Revascularisation (repeat treatment of narrowing), Myocardial Infarction (heart attack) related to the target vessel, or Cardiac Death (participant death) related to the target vessel.
Interventions
The Everolimus-Eluting Coronary Stent System (PROMUS Element) is a metal tube coated with the drug Everolimus. Up to two stents 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 eluted into the bloodstream following implantation of the stent. Stent size is selected by the investigator based o
The Everolimus-Eluting Coronary Stent System (PROMUS Element) is a metal tube coated with the drug Everolimus. Up to two stents 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 eluted into the bloodstream following implantation of the stent. 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 Corporation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 150 Years
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 coromary artery with diameter >2.50mm and <4.25mm 6. Target lesion must be <24mm 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 30 days 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
Outcome results
None listed