ACTRN12609000724279
Recruiting
未知
A Prospective, Multicentre Trial to assess the safety & effectiveness of anEverolimus-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 Ltd0 sites102 target enrollmentAugust 24, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Boston Scientific Pty Ltd
- Enrollment
- 102
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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\.5mm to 4\.25mm
- •6\. Target lesion must be 24mm to 34mm in length
- •7\. Target lesion must be in a major coronaryartery 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 pregant, nursing/lactating or planning to procreate within 12 months of the index procedure
Outcomes
Primary Outcomes
Not specified
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