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PROMUS Element Japan Small Vessel Trial

NCT01080261 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-03-29

Study results available
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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.

Conditions

Interventions

DEVICE

PROMUS Element

PROMUS Element Everolimus-Eluting Coronary Stent System

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Shigeru Saito, MD · Shonan Kamakura General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-03-31
Completion
2012-12-31

Countries

  • Japan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01080261 on ClinicalTrials.gov