Status:
WITHDRAWN
COmplex BifuRcation Lesions: A Comparison Between the AXXESS Device and Culotte Stenting: An Optical Coherence Tomography (OCT) Study
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Coronary Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to compare vessel healing at 9 months using OCT imaging for two different treatment techniques for treating bifurcation lesions. Quantitative assessment of OCT images will be ...
Detailed Description
Background: There is an ongoing controversy over the efficacy and safety of different bifurcation stenting techniques. Critical considerations are the rate of restenosis at the side branch ostium, and...
Eligibility Criteria
Inclusion
- Patient older than 18 years
- Written informed consent available
- Patient eligible for percutaneous coronary intervention
- Patients with a de novo and true coronary bifurcation lesion (Medina classification (1,1,1), (1,0,1) or (0,1,1))
- Target reference vessel diameter measured by QCA: 2-4 mm
- Target lesion stenosis measured by QCA: \> 70% - \< 100%
- Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations
Exclusion
- Left ventricular ejection fraction of \< 30%
- Impaired renal function (serum creatinine \> 2.0 mg/dl)
- Previous and/or planned brachytherapy of target vessel
- Lesion of the left main trunk \> 50%, unprotected
- Known allergies to antiplatelet, anticoagulation therapy, contrast media or everolimus
- Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required)
- Patients with a life expectancy of less than one year
- Patient currently enrolled in other investigational device or drug trial
- Patient not able or willing to adhere to follow-up visits
- Patients who intend to have a major surgical intervention within 6 months of enrolment in the study
- Patient not able or willing to adhere to follow-up visits
- Patients who previously participated in this study
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00895791
Start Date
June 1 2009
End Date
December 1 2015
Last Update
January 27 2023
Active Locations (1)
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1
UZ Leuven Cardiology
Leuven, Belgium, 3000