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

2014-07-24 14:01:09 | BioPortfolio

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Coronary Artery Disease

Intervention

PROMUS(TM) Element (TM) Stent System, Evolution Stent System

Status

Not yet recruiting

Source

Boston Scientific Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:01:09-0400

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