The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study
NCT ID: NCT02234804
Last Updated: 2015-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2013-07-31
2017-02-28
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Medtronic Resolute Integrity stent
Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium
Angiography
OCT
OCT
OCT to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation.
Xience Prime Stent
Medtronic Resolute Integrity stent
Angiography
Angiography to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation.
Xience Prime Stent
Medtronic Resolute Integrity stent
Xience Prime stent
Comparing Medtronic Resolute Integrity and Xience Prime for stent strut apposition in the SB ostium
Angiography
OCT
Interventions
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Xience Prime Stent
Medtronic Resolute Integrity stent
Angiography
OCT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* De novo coronary bifurcation lesions at "LAD/diagonal", "Cx/obtuse marginal", "right coronary artery (RCA)- posterior descending artery (PDA)/posterolateral branch" or "left main (LM)/Cx/LAD".
* All Medina classes except Medina 0.0.1.
* Diameter of side branch ≥2.5 mm.
* Diameter stenosis \>50% by operator's visual assessment
* Signed informed consent
Exclusion Criteria
* Side branch lesion length \>5 mm.
* Expected survival \< 1 year
* Severe heart failure (NYHA≥III)
* S-creatinine \>120 µmol/l.
* Allergy to Contrast media, Aspirin, Clopidogrel, Ticagrelor, Ticlopidine, Everolimus or Zotarolimus.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Medtronic
INDUSTRY
Aarhus University Hospital Skejby
OTHER
Responsible Party
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Niels Ramsing Holm
MD
Principal Investigators
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Niels R Holm, MD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital Skejby
Locations
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University Hospitals Leuven
Leuven, , Belgium
Aarhus University Hspital
Aarhus N, , Denmark
Royal Brompton Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Tom Adriaenssens, MD
Role: primary
Carlo DiMario, MD
Role: primary
Other Identifiers
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1-10-72-111-13
Identifier Type: -
Identifier Source: org_study_id
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