Coronary Artery Disease Clinical Trial
Official title:
STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion (SXS-CTO)
Intro: Chronic total occlusions (CTO) are the most severe coronary lesions. Negative distal
vessel remodeling occurs in these lesions, leading to reduction of artery diameter. Treatment
of CTO with percutaneous coronary intervention (PCI) is associated with good clinical
outcomes. However, QCA and IVUS studies showed a notable lumen and vessel enlargement distal
to recanalized CTO. In addition, optical tomography (OCT) studies showed high rates of stent
strut malapposition and incomplete stent strut coverage after CTO PCI. The Stentys Xposition
S is a self-apposing stent device which lowers stent strut malapposition rates. Its safety
and effectiveness has been demonstrated in STEMI and stable coronary patients but never
investigated in CTO lesions.
Hypothesis/Objective To investigate whether self-expanding stents are more effective than
balloon-expandable stents for reducing stent malapposition at 6 months after implantation in
patients with CTO undergoing percutaneous coronary intervention.
Method Pilot randomized study. Patients are randomized to receive either self-expandable
stent or balloon expandable stent to perform CTO-PCI. Follow-up coronary angiography is
performed at 6 months post-PCI. Stent malapposition is evaluated by OCT.
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