A Prospective Evaluation in a 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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Coronary Heart Disease
- Sponsor
- National University Hospital, Singapore
- Last Updated
- 17 years ago
Overview
Brief Summary
This study is to compare the safety and performance of two stents coated with the same drug (the TAXUS Element Paclitaxel-Eluting Coronary Stent System and the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System).
Detailed Description
Approximately 1264 subjects at a maximum of 100 clinical sites will be part of this study. This study will recruit approximately 30 subjects from NHC \& NUH (12 from NUH) over a period of 6 to 9 months recruitment period. Paclitaxel is the active ingredient in Taxol®, a drug originally developed to treat cancer. The addition of the paclitaxel coating to the stent could improve the performance of the stent by preventing the re-narrowing of the treated coronary artery. This re-narrowing is called restenosis. Restenosis can occur after balloon angioplasty or the placement of a stent and is the result of too much cell growth at the treatment site in the coronary artery. The TAXUS Element stent is an investigational device. The term investigational means that the stent is not currently approved for commercial use by the FDA or other regulatory agencies worldwide. The TAXUS Express 2 stent is also a coronary stent made with the same drug coating as the Element stent. It is approved for commercial use by the FDA and other regulatory agencies worldwide, with the exception of the 4.0 mm size, which is not yet approved by the FDA. However, the 4.0 mm size was studied for safety and performance in a clinical trial and the results of that trial have been submitted to FDA to support approval. FDA has agreed that the 4.0 mm size may be used in this trial. Paclitaxel was selected as the drug to coat the stent because it is known to prevent the uncontrolled cell growth that contributes to the narrowing of artery, by interfering with the ability of cells to divide and multiply. Because of these properties, it has been used as a drug for the treatment of various types of cancer. Cancer patients are given paclitaxel as a solution into the vein. For this study, paclitaxel will be administered locally to the wall of coronary artery as a coating on the stent. Cancer patients receive a dose of paclitaxel approximately 1100 - 1400 times greater than the dose used in the coating of the stent. It is highly unlikely that levels of paclitaxel in the blood would be measurable or have effects anywhere beyond the heart.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical Inclusion Criteria
- •Subject is ≥ 18 years old and ≤ 80 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 with documented ischemia (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
- •Angiographic Inclusion Criteria (visual estimate)
- •Target lesion located in native coronary artery
Exclusion Criteria
- •Clinical Exclusion Criteria
- •Contraindication to 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
Outcomes
Primary Outcomes
Not specified