Phase 3
Completed N=349
TAXUS PERSEUS Small Vessel
Source: ClinicalTrials.gov NCT00489541 ↗Enrolled (actual)
349
Serious AEs
48.7%
Results posted
Jun 2011
Primary outcomePrimary: In-stent Late Loss Measured by Quantitative Coronary Angiography (QCA) — 0.38; 0.80 millimeter — p=<0.0001
Summary
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 20 mm in length in native coronary arteries of ≥ 2.25 mm to < 2.75 mm diameter.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY In-stent Late Loss Measured by Quantitative Coronary Angiography (QCA) |
0.38; 0.80 | <0.0001 sig |
| SECONDARY Number of Participants With Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel. |
16; 27 | <0.0001 sig |
Eligibility Criteria
Clinical Inclusion Criteria:
- Subject is ≥ 18 years old
- Eligible for percutaneous coronary intervention (PCI)
- Documented stable angina pectoris (Canadian Cardiovascular Society [CCS] Classification 1, 2, 3, or 4) or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia
- Acceptable candidate for coronary artery bypass grafting (CABG)
- Left ventricular ejection fraction (LVEF) is ≥ 30%
- Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
- Subject willing to comply with all specified follow-up evaluations
Clinical Exclusion Criteria:
- Contraindication to aspirin (ASA), or to both clopidogrel and ticlopidine
- Known hypersensitivity to paclitaxel
- Known allergy to stainless steel
- Known allergy to platinum
- Previous treatment of the target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent
- Previous treatment of the target vessel with a bare metal stent (BMS) within 9 months of the index procedure
- Previous treatment of any non-target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent within 9 months of the index procedure
- Previous treatment with intravascular brachytherapy in the target vessel
- Planned PCI or CABG post-index procedure
- Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement
- Myocardial infarction (MI) within 72 hours prior to index procedure
- Cerebrovascular accident (CVA) within the past 6 months
- Cardiogenic shock
- Acute or chronic renal dysfunction
- Prior anaphylactic reaction to contrast agents
- Leukopenia
- Thrombocytopenia
- Thrombocytosis
- Active peptic ulcer or active gastrointestinal (GI) bleeding
- Current treatment, or past-treatment within 12-months of the index procedure, with paclitaxel or other chemotherapeutic agents
- Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
- Known intention to procreate within 9 months after the index procedure
- Positive pregnancy test within 7 days before the index procedure, or lactating
- Life expectancy of less than 24 months due to other medical conditions
- Co-morbid condition(s) that could limit subject's ability to comply with study follow-up requirements or impact study scientific integrity
- Currently participating in another investigational drug or device study
Angiographic Inclusion Criteria:
- Target Lesion
- Target lesion located in native coronary artery
- Target lesion must be de novo
- Target lesion diameter stenosis ≥ 50%
- Reference vessel diameter (RVD) ≥ 2.25 mm to 60° bend in target vessel
- Target vessel with angiographic presence of probable or definite thrombus
- Unprotected left main coronary artery disease
- Protected left main coronary artery disease with target lesion in Left Anterior Descending artery (LAD) or Left Circumflex artery (LCx). Subject may be enrolled if only lesion is target lesion in Right Coronary Artery (RCA)
Data sourced from ClinicalTrials.gov (NCT00489541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.