PROMUS Element Japan Small Vessel Trial

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01080261
Study type	Interventional
Source	Boston Scientific Corporation
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	February 2010
Completion date	November 2015

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