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Clinical Trial Summary

The purpose of the trial is to directly compare the Cobalt Chromium platform everolimus-eluting stent, Xience Primeâ„¢, with the Platinum Chromium platform everolimus-eluting stent, Promus Elementâ„¢, in relation to stent scaffolding shape, position with the heart blood vessel and extent of tissue coverage (at 6 months) using optical coherence tomography.

Hypotheses:

1. The alloy composition and strut design of a drug-eluting stent has a direct bearing on stent apposition measured using OCT.

2. Stent design and alloy composition have a direct influence on radial support and scaffold shrinkage.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)


Related Conditions & MeSH terms


NCT number NCT01776567
Study type Interventional
Source Northern Hospital, Australia
Contact Peter Barlis, MBBS MPH PHD FESC FRACP
Phone +61 3 8405 8554
Email pbarlis@unimelb.edu.au
Status Recruiting
Phase Phase 4
Start date July 2012
Completion date June 2015

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