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

NCT02234804 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-10-06

No results posted yet for this study

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.

Conditions

  • Coronary Disease

Interventions

DEVICE

Xience Prime Stent

DEVICE

Medtronic Resolute Integrity stent

PROCEDURE

Angiography

PROCEDURE

OCT

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Medtronic

    collaborator INDUSTRY

  • Aarhus University Hospital Skejby

    lead OTHER

Principal Investigators

  • Niels R Holm, MD · Aarhus University Hospital Skejby

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-12-31
Completion
2017-02-28

Countries

  • Belgium
  • Denmark
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02234804 on ClinicalTrials.gov