Status:
UNKNOWN
The Does Optical Coherence Tomography Optimize Revascularization (DOCTOR) Recross Study
Lead Sponsor:
Aarhus University Hospital Skejby
Collaborating Sponsors:
Abbott Medical Devices
Medtronic
Conditions:
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective, controlled, double randomized, non-blinded, multicenter, investigator initiated, academic superiority trial comparing optical coherence tomography (OCT) guided vs. angiography guided wire...
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 differe...
Eligibility Criteria
Inclusion
- Stable or unstable angina pectoris or silent angina pectoris.
- 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
- ST-elevation infarction within 48 hours.
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02234804
Start Date
July 1 2013
End Date
February 1 2017
Last Update
October 6 2015
Active Locations (3)
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1
University Hospitals Leuven
Leuven, Belgium, 3000
2
Aarhus University Hspital
Aarhus N, Denmark, 8200
3
Royal Brompton Hospital
London, United Kingdom