TAXUS PERSEUS Small Vessel (PERSEUS SV)
|Coronary Artery Disease||Device: Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation||Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- In-stent Late Loss Measured by Quantitative Coronary Angiography (QCA) [ Time Frame: 9 months post-index procedure ]Post-procedure minimum lumen diameter (mm) minus follow-up minimum lumen diameter as determined by quantitative angiography. Minimum lumen diameter is measured within the stent at each time point.
- 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. [ Time Frame: 12 months post-index procedure ]The number of participants who experience a TLF through 365 days post-procedure out of the patients who have either had a TLF within 365 days post-procedure or who were TLF-free with last follow-up at least 335 days post-procedure.
|Study Start Date:||July 2007|
|Study Completion Date:||October 2013|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
|Experimental: TAXUS Element Stent System||
Device: Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
TAXUS Element stent implantation
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 ≤20 mm in length in native coronary arteries with visual RVD of ≥ 2.25 mm to < 2.75 mm 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489541
Show 28 Study Locations
|Principal Investigator:||Dean J Kereiakes, MD||The Christ Hospital|
|Principal Investigator:||Louis A Cannon, MD||Cardiac and Vascular Research Center of Northern Michigan|