NCT01285999

Prospective, Randomized, Multicenter Trial to Assess PROMUS™ Element™ Stent

PLATINUM China: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS™ Element™) for the Treatment of a Single De Novo Coronary Artery Lesion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 subjects in China with a single de novo atherosclerotic coronary artery lesion.

Detailed description

A prospective, multi-center, randomized-controlled, single-blind, superiority trial at up to 15 sites in China to enroll 500 subjects (3:1 randomization PROMUS Element to TAXUS Liberté) with a single de novo lesion \<38mm in length (by visual estimate) in a native coronary artery ≥2.50mm to ≤4.00 mm in diameter (by visual estimate).

Conditions

• Atherosclerosis
• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	PROMUS Element Coronary Stent System	Everolimus-eluting Coronary Stent Drug-eluting Stent (DES) implantation
DEVICE	TAXUS Liberté Coronary Stent System	Paclitaxel-eluting Coronary Stent Drug-eluting Stent (DES) implantation

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-03-01
• Completion: 2014-08-01
• First posted: 2011-01-31
• Last updated: 2025-03-11
• Results posted: 2024-11-20

Locations

15 sites across 1 country: China