NCT00484315

TAXUS PERSEUS Workhorse

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,264 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the TAXUS PERSEUS Workhorse 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 28 mm in length in native coronary arteries of 2.75 mm to 4.0 mm diameter.

Detailed description

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation	TAXUS Element stent placement
DEVICE	Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement	TAXUS Express Stent Implant

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-09-01
• Completion: 2013-10-01
• First posted: 2007-06-08
• Last updated: 2014-05-08
• Results posted: 2011-06-28

Locations

90 sites across 4 countries: United States, Australia, New Zealand, Singapore