TAXUS PERSEUS Small Vessel (PERSEUS SV)
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|ClinicalTrials.gov Identifier: NCT00489541|
Recruitment Status : Completed
First Posted : June 21, 2007
Results First Posted : June 28, 2011
Last Update Posted : May 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||224 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2007|
|Primary Completion Date :||June 2009|
|Study Completion Date :||October 2013|
|Experimental: TAXUS Element Stent System||
Device: Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
TAXUS Element stent implantation
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|