None listed
Conditions
Brief summary
PLATINUM QCA is a prospective, multicenter trial to assess PROMUS Element for the treatment of patients with a maximum of 1 de novo atherosclerotic coronary artery lesion of up to 34 mm in total length (by visual estimate) in native coronary arteries =2.25 mm to =4.25 mm in diameter (by visual estimate). Approximately 100 non-randomized patients at up to 20 sites are proposed to obtain clinical outcomes data for the PROMUS Element stent system. Follow up occurs at 30 days, 9 months and 12 months with both QCA and IVUS assessments at 9 months. The Primary Endpoint is Cardiac events at 30 days post-index procedure (Myocardial infarction (MI, Q-wave and non-Q wave) rate; Cardiac death rate; Target lesion failure (TLF) rate; Target lesion revascularization (TLR) rate; Stent thrombosis (ST) rate (definite or probable by Academic Research Consortium [ARC] definitions) with an efficacy endpoint of 9 month in-stent late loss and post-procedure incomplete apposition.
Interventions
The Everolimus-Eluting Coronary Stent System (PROMUS Element) is a metal tube coated with the drug Everolimus. A single 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 eluted into the blood stream following implantation of the stent. Stent size is selected by the investigator based on
The Everolimus-Eluting Coronary Stent System (PROMUS Element) is a metal tube coated with the drug Everolimus. A single 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 eluted into the blood stream 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
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 doucmented stable angina pectoris, or documented silent ischaemia, or unstable angina pectoris 3. Patient is acceptable candidate for CABG 4. Patient has left ventricular ejection fraction 0f >30% 5. Target lesion must be de novo and located within native coronary artery with diameter >2.25mm and <4.25mm 6. Target lesion must be <34mm 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 of 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