TAXUS PERSEUS Workhorse (PERSEUS WH)
|ClinicalTrials.gov Identifier: NCT00484315|
Recruitment Status : Completed
First Posted : June 8, 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 Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement||Phase 3|
This is a prospective, 3:1 randomization, multi-center trial to assess the TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System for the treatment of de novo atherosclerotic lesions of up to 28 mm in length in native coronary arteries ≥ 2.75 mm and ≤ 4.0 mm in diameter, compared to a control group of TAXUS Express2 Paclitaxel-Eluting Coronary Stent System .
One thousand two hundred sixty-four (1264) subjects will be treated with either the TAXUS® Element™ stent or the TAXUS® Express2 ™stent at a maximum of 100 clinical sites. Randomization to treatment group will be unbalanced 3:1 towards the test group to gain maximum clinical experience with the new TAXUS® Element™ platform. Follow-up at 30 days, 9 months and 12 months will be completed in all subjects enrolled in the study. Angiographic follow-up at 9 months will be completed in a subset of three hundred thirty (330) subjects enrolled in the study. Subjects will be randomly allocated to the angiographic subset at participating sites through the Interactive Voice Response System (IVRS).
Eligible subjects will have annual follow-up until 5 years post-index procedure.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1264 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||October 2013|
|Experimental: TAXUS Element||
Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
TAXUS Element stent placement
|Active Comparator: TAXUS Express||
Device: Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement
TAXUS Express Stent Implant
- 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 participants 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.
- In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure [ Time Frame: 9 months post-index procedure ]The minimum lumen diameter in the analysis segment at 9-months post-index procedure, divided by the reference vessel diameter at baseline. The analysis segment ("in-segment") is defined as the proximal edge, stented area, and the distal edge, where each edge segment contains up to 5mm immediately outside the stent.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484315
Show 90 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|