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Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms

NCT01776567 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-08-05

No results posted yet for this study

Summary

The purpose of the trial is to directly compare the Cobalt Chromium platform everolimus-eluting stent, Xience Prime™, with the Platinum Chromium platform everolimus-eluting stent, Promus Element™, 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.

Conditions

Interventions

DEVICE

Everolimus eluting stents

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Northern Hospital, Australia

    lead OTHER

Principal Investigators

  • Peter Barlis · Northern Hospital

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-12-31
Completion
2015-06-30

Countries

  • Australia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01776567 on ClinicalTrials.gov