NCT01080261

PROMUS Element Japan Small Vessel Trial

A Prospective Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of a Small Vessel De Novo Coronary Artery Lesion in Japan

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

• Atherosclerosis
• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	PROMUS Element	PROMUS Element Everolimus-Eluting Coronary Stent System

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-03-01
• Completion: 2012-12-01
• First posted: 2010-03-04
• Last updated: 2016-03-29
• Results posted: 2012-04-12

Locations

15 sites across 1 country: Japan