Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-11 @ 5:04 PM
Study NCT ID:
NCT02946320
Status:
UNKNOWN
Last Update Posted:
2016-10-27
First Post:
2016-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Predilatation Technique for BVS Implantation
Sponsor:
Cardiology Center Agel
Organization:
Study Overview
Official Title:
Optimal Predilatation Technique for BVS Implantation
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
NOT_YET_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:
OPTI-BVS
Brief Summary:
The purpose of this study is to determine the optimal way of predilatation for BVS implantation.
Detailed Description:
Randomized, single-center study. Forty-five patients with intended BVS implantation will be randomized in ratio of 1:1:1 to different predilatation strategies(non-compliant balloon/Emerge NC™, Boston Scientific, cutting balloon/Flexitome™, scoring balloon/Scoroflex™,Orbus). Predilatation is intended to be done in a vessel:balloon ratio of 1:1. If the device is not able enter the lesion, it will be replaced with a conventional semicompliant balloon with the same predilatation strategy (a vessel:balloon ratio of 1:1) After a successful predilatation, the BVS (Absorb™, Abbott) will be implanted and this procedure will be accomplished by a high pressure postdilatation with a non-compliant balloon (Emerge NC™, BSCI). The MLA of the Absorb stent will be evaluated with optical coherence tomography (OPTIS, St.Jude).
Study Oversight
Has Oversight DMC:
False
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?: