Evaluation of the Safety & Effectiveness of the PROMUS Element Everolimus-Eluting Coronary Stent System in patients with new or untreated atherosclerotic coronary artery lesions in a small vessel (2.25-2.5mm in diameter)
- Conditions
- Atherosclerotic lesions in the coronary arteryCardiovascular - Coronary heart disease
- Registration Number
- ACTRN12609000725268
- Lead Sponsor
- Boston Scientific Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 94
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%
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 12-month target lesion failure (TLF) rate, defined as any ischaemia-driven revascularisation of the target lesion (TLR), myocardial infarction (MI) (Q-wave and non-Qwave) related to the target vessel, or cardiac death related to the target vessel[12 months after intervention]
- Secondary Outcome Measures
Name Time Method