Evaluation of the Safety & Effectiveness of the PROMUS Element Everolimus-Eluting Coronary Stent System in patients with new or untreated atherosclerotic coronary artery lesions

Not Applicable

Recruiting

• Conditions: Atherosclerotic lesions in the coronary artery; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12609000724279
• Lead Sponsor: Boston Scientific Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 102

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

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]