Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-29 @ 12:42 AM
Study NCT ID:
NCT01776567
Status:
UNKNOWN
Last Update Posted:
2014-08-05
First Post:
2012-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms
Sponsor:
Northern Hospital, Australia
Organization:
Study Overview
Official Title:
Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms.
Status:
UNKNOWN
Status Verified Date:
2014-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APPOSE
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: