NCT03563989

STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion

STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion (SXS-CTO)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Total Occlusion
• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Implantation of Stent (PCI)	Treatment of CTO with Percutaneous Coronary Intervention (PCI) Patients are randomized to receive either self-expandable stent or balloon expandable stent

Timeline

• Start date: 2018-06-26
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2018-06-20
• Last updated: 2018-08-13

Locations

1 site across 1 country: France