NCT00489541

TAXUS PERSEUS Small Vessel

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the TAXUS PERSEUS Small Vessel 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 20 mm in length in native coronary arteries of ≥ 2.25 mm to \< 2.75 mm diameter.

Detailed description

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation	TAXUS Element stent implantation

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-06-01
• Completion: 2013-10-01
• First posted: 2007-06-21
• Last updated: 2014-05-08
• Results posted: 2011-06-28

Locations

28 sites across 1 country: United States