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

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Coronary Artery Disease; Chronic Total Occlusion

Treatments: Device: Implantation of Stent (PCI)

Study type: Interventional

Funder types: Other

Identifiers

NCT03563989

K171009J

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Stentys Xposition S Self-Apposing stent

Experimental group

Description:

STENTYS Xposition S Sirolimus Eluting Self-Apposing Coronary Stent System

Treatment:

Device: Implantation of Stent (PCI)

Conventional Balloon-expandable stent

Active Comparator group

Description:

Conventional Balloon-expandable drug eluting stents in effect at the time of the study, in compliance with applicable contracts made between Hospital and suppliers.

Treatment:

Device: Implantation of Stent (PCI)