NCT01135225

Non-inferiority Trial to Assess the Safety and Performance of the Evolution Coronary Stent

EVOLVE: A Prospective Randomized Multicenter Single-blind Non-inferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System (Evolution Stent System) for the Treatment of a De Novo Atherosclerotic Lesion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 291 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the EVOLVE Trial is to assess the safety and performance of the everolimus-eluting Evolution stent for the treatment of a de novo atherosclerotic lesion of up to 28 mm in length in a native coronary artery 2.25 mm to 3.5 mm in diameter. The safety and performance of two different drug release rate formulations of the Evolution Stent will be compared to the commercially available PROMUS (TM) Element (TM) drug-eluting stent.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	PROMUS(TM) Element (TM) Stent System	The PROMUS Element Everolimus-Eluting Coronary Stent System is a device/drug combination product composed of two components: a device (coronary stent system) and a drug product (a formulation of everolimus contained in a polymer coating.
DEVICE	Evolution Stent System	The Evolution Everolimus-Eluting Monorail Coronary Stent System is a device/drug combination comprised of two regulated components: a device (coronary stent stent) and a drug product (a formulation of everolimus contained in a biodegradable polymer coating).

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-08-01
• Completion: 2016-04-01
• First posted: 2010-06-02
• Last updated: 2017-02-03

Locations

29 sites across 9 countries: Australia, Belgium, Denmark, France, New Zealand, Poland, Spain, Sweden, United Kingdom