Coronary Disease Clinical Trial
Official title:
The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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