WithdrawnNot Applicable

COmplex BifuRcation Lesions: A Comparison Between the AXXESS Device and Culotte Stenting: An Optical Coherence Tomography (OCT) Study

Stopped: major protocol changes: new study submitted

Belgium0Started 2009-06

Plain-language 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 used to assess re-endothelialization and quality of strut apposition to the vessel wall.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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)
✕

What they're measuring

The primary endpoint is % stent strut coverage and % stent strut apposition, assessed with optical coherence tomography, at 9 months follow-up.

Timeframe: 9 months

Trial details

NCT IDNCT00895791

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-12

View on ClinicalTrials.gov More Coronary Artery Stenosis trials