CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 94 enrolled
Drug / intervention
PROMUS Element Coronary Stent Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01498692
NCT01498692N/ACompleted
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PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions - Small Vessel Sub-trial

Boston Scientific Corporation·interventional·Posted Dec 23, 2011·Updated Mar 26, 2019

In Brief

A clinical study evaluating PROMUS Element Coronary Stent System for Coronary Artery Disease. Completed, enrolled 94 participants across 23 sites in 6 countries.

Detailed Summary

The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions. The lesions can be located in vessels that are smaller than average-sized.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesAustralia, Belgium, France, Japan, New Zealand, United States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 23, 2011
Enrollment StartFeb 1, 2009
Primary CompletionDec 1, 2010
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.5 years ago

Interventions

PROMUS Element Coronary Stent Systemdevice

PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating)