STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion

NCT ID: NCT03563989

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-26
• Study Completion Date: 2019-12-31

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.

Conditions

Chronic Total Occlusion; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stentys Xposition S Self-Apposing stent

STENTYS Xposition S Sirolimus Eluting Self-Apposing Coronary Stent System

Group Type: EXPERIMENTAL

Implantation of Stent (PCI)

Intervention Type: DEVICE

Treatment of CTO with Percutaneous Coronary Intervention (PCI) Patients are randomized to receive either self-expandable stent or balloon expandable stent

Conventional Balloon-expandable stent

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

Group Type: ACTIVE_COMPARATOR

Implantation of Stent (PCI)

Intervention Type: DEVICE

Treatment of CTO with Percutaneous Coronary Intervention (PCI) Patients are randomized to receive either self-expandable stent or balloon expandable stent

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Créteil, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

MADJID BOUKANTAR, MD

Role: primary

madjid.boukantar@aphp.fr

+33149812111

Other Identifiers

K171009J

Identifier Type: -

Identifier Source: org_study_id