Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-29 @ 1:28 PM
Study NCT ID:
NCT02234804
Status:
UNKNOWN
Last Update Posted:
2015-10-06
First Post:
2014-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study
Sponsor:
Aarhus University Hospital Skejby
Organization:
Study Overview
Official Title:
The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study
Status:
UNKNOWN
Status Verified Date:
2015-10
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:
DOCTOR Recross
Brief Summary:
Prospective, controlled, double randomized, non-blinded, multicenter, investigator initiated, academic superiority trial comparing optical coherence tomography (OCT) guided vs. angiography guided wire recrossing in jailed side branches (SB) (1. randomization 1:1)(superiority) and comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium (2. randomization 1:1) (superiority). Acute primary endpoint and 30 days clinical follow-up.
Hypothesis: OCT guided wire recrossing in bifurcation stenting results in less malapposed struts in the segment facing the SB ostium.
Secondary hypothesis: Treatment by Medtronic Resolute Integrity stent results in less malapposed struts at the bifurcation segment compared to treatment by the Abbott Xience Prime stent.
Hypothesis: OCT guided wire recrossing in bifurcation stenting results in less malapposed struts in the segment facing the SB ostium.
Secondary hypothesis: Treatment by Medtronic Resolute Integrity stent results in less malapposed struts at the bifurcation segment compared to treatment by the Abbott Xience Prime stent.
Detailed Description:
Purpose:
To assess the ability of OCT to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation.
To compare stent strut apposition after treatment by two different stent designs using both guiding strategies of wire recrossing.
To assess the ability of OCT to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation.
To compare stent strut apposition after treatment by two different stent designs using both guiding strategies of wire recrossing.
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?: