NCT02234804

The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Aarhus University Hospital Skejby · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Coronary Disease

Interventions

Type	Name	Description
DEVICE	Xience Prime Stent
DEVICE	Medtronic Resolute Integrity stent
PROCEDURE	Angiography
PROCEDURE	OCT

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-12-01
• Completion: 2017-02-01
• First posted: 2014-09-09
• Last updated: 2015-10-06

Locations

3 sites across 3 countries: Belgium, Denmark, United Kingdom