Coronary Artery Disease - TAXUS PERSEUS - Small Vessel
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Trial Sponsor
Boston Scientific
Principal Investigator
Gregory Mishkel, MD
Trial Name
A Prospective Evaluation in a Non-Randomized Trial of the Safety and Efficacy of the Use of the TAXUS® ElementTM Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions in Small Vessels
Purpose
The purpose of the TAXUS PERSEUS Small Vessel trial is to evaluate the
safety and efficacy of the next-generation Boston Scientific TAXUS paclitaxel-eluting coronary stent system (TAXUS® ElementTM) for the treatment of de novo atherosclerotic lesions of up to 20mm in length in native coronary arteries of ≥ 2.25 mm to < 2.75mm diameter.
Details
This is a prospective, multi-center, single-arm superiority trial to assess
the TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System for the treatment of de novo atherosclerotic lesions of ≤20mm in length in native coronary arteries with visual RVD of ≥ 2.25 mm to < 2.75mm diameter.
Two hundred twenty-four (224) subjects will be treated with the TAXUS Element stent at a maximum of 35 clinical sites. Follow-up at 30 days, 9 months including angiography) and 1 year will be completed in all subjects enrolled in the study. Eligible subjects will have annual follow-up until 5 years post-index procedure.
Eligibility
Ages Eligible for Study
18 years to 80 years
Genders Eligible for Study
Both
Inclusion Criteria
Key Clinical Inclusion Criteria:
- Subject is ≥ 18 years old and ≤ 80 years old
- Eligible for percutaneous coronary intervention (PCI)
- Documented stable angina pectoris or unstable angina pectoris with documented ischemia, or documented silent ischemia
Key Angiographic Inclusion Criteria:
- Target Lesion
- Reference vessel diameter (RVD) ≥ 2.25 mm to < 2.75 mm
- Cumulative target lesion length ≤ 20 mm
Exclusion Criteria
Key Clinical Exclusion Criteria:
- Contraindication to ASA, or to both clopidogrel and ticlopidine
- Myocardial infarction (MI) within 72 hours prior to index procedure
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