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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Treatment of CTO with Percutaneous Coronary Intervention (PCI) Patients are randomized to receive either self-expandable stent or balloon expandable stent
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, France
RECRUITINGstrut malapposition at six months measured by OCT
Time frame: 6 months after CTO-PCI
percentage of uncovered struts
Time frame: 6 months after CTO-PCI
lumen diameter (mm)
Time frame: 6 months after CTO-PCI
Restenosis
Time frame: 6 months after CTO-PCI
Angina pectoris
Time frame: 6 months after CTO-PCI
Dyspnea
Time frame: 6 months after CTO-PCI
Mortality
Time frame: 6 months after CTO-PCI
Stroke
Time frame: 6 months after CTO-PCI
Stent thrombosis
Time frame: 6 months after CTO-PCI
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