ACTRN12608000582358Active, not recruiting未知
A Prospective, Randomised, Multicentre Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element) for the Treatment of up to two De Novo Coronary Artery Lesions
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Active, not recruiting
- Enrollment
- 1,532
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 150 Years (—)
- Sex
- All
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
Investigators
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