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PROMUS Element Japan Small Vessel Trial

2014-07-23 21:09:56 | BioPortfolio

Summary

A non-randomized, small vessel (SV) trial at approximately 15 sites in Japan to enroll 60 patients with a de novo lesion ≤28 mm in length (by visual estimate) in a native coronary artery ≥2.25 mm to <2.50 mm in diameter (by visual estimate). Approximately thirty patients will be randomly assigned to the angiographic subset to also undergo angiographic assessment after the 12-month clinical follow-up.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Atherosclerosis

Intervention

PROMUS Element™

Location

Shonan Kamakura General Hospital
Kamakura-shi
Kanagawa-ken
Japan

Status

Recruiting

Source

Boston Scientific Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:56-0400

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