STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion

Not Applicable

• Conditions: Coronary Artery Disease; Chronic Total Occlusion
• Interventions: Device: Implantation of Stent (PCI)

• Registration Number: NCT03563989
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-05-28
• Study First Submitted QC: 2018-06-10
• Study First Posted: 2018-06-20
• Study Start: 2018-06-26
• Last Update Submitted: 2018-08-10
• Last Update Posted: 2018-08-13
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Balloon-expandable stent	Implantation of Stent (PCI)	Conventional Balloon-expandable drug eluting stents in effect at the time of the study, in compliance with applicable contracts made between Hospital and suppliers.
Stentys Xposition S Self-Apposing stent	Implantation of Stent (PCI)	STENTYS Xposition S Sirolimus Eluting Self-Apposing Coronary Stent System

Primary Outcome Measures

Name	Time	Method
strut malapposition at six months measured by OCT	6 months after CTO-PCI

Secondary Outcome Measures

Name	Time	Method
Restenosis	6 months after CTO-PCI
percentage of uncovered struts	6 months after CTO-PCI
lumen diameter (mm)	6 months after CTO-PCI
Angina pectoris	6 months after CTO-PCI
Stroke	6 months after CTO-PCI
Stent thrombosis	6 months after CTO-PCI
Mortality	6 months after CTO-PCI
Dyspnea	6 months after CTO-PCI

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR; 🇫🇷 Créteil, France