STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion

Coronary Artery Disease Clinical Trial

— SXS-CTO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03563989
• Other study ID #: K171009J
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2018
• Est. completion date: December 2019

Study information

• Verified date: May 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age = 18 years;

• CTO referred for PCI

• Diameter of the Target vessel for PCI between 2.5 and 4.5mm

• Agreement to participate and signed informed consent after information

• Affiliation to Social Security System

• French comprehension

Exclusion Criteria:

• Pregnant women, breast-feeding,

• History of an allergic reaction or significant sensitivity to any stent component or to contrast dye

• Intrastent CTO

• Major calcifications in the CTO

• Inclusion in another interventional study

• Person under guardianship or curatorship

Related Conditions & MeSH terms

• Chronic Total Occlusion
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	strut malapposition at six months measured by OCT		6 months after CTO-PCI
Secondary	percentage of uncovered struts		6 months after CTO-PCI
Secondary	lumen diameter (mm)		6 months after CTO-PCI
Secondary	Restenosis		6 months after CTO-PCI
Secondary	Angina pectoris		6 months after CTO-PCI
Secondary	Dyspnea		6 months after CTO-PCI
Secondary	Mortality		6 months after CTO-PCI
Secondary	Stroke		6 months after CTO-PCI
Secondary	Stent thrombosis		6 months after CTO-PCI