CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 102 enrolled
Drug / intervention
Aspirin +2 moredrug
Likely dose
Aspirin 325 mgfrom 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/NCT01500434
NCT01500434Phase 3Completed
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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 - Long Lesion Sub-trial

Boston Scientific Corporation·interventional·Posted Dec 28, 2011·Updated Mar 26, 2019

In Brief

A Phase 3 clinical trial evaluating PROMUS Element Coronary Stent System, Aspirin, and 1 other intervention for Coronary Artery Disease. Completed, enrolled 102 participants across 30 sites in 7 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 longer than average-sized.

Study Details

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

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 28, 2011
Enrollment StartFeb 1, 2009
Primary CompletionMar 1, 2011
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 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).

Aspirindrug

Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.

Thienopyridinedrug

Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.