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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Chronic Total Occlusion
• Intervention / Treatment: Device: Implantation of Stent (PCI)

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94010
    • Recruiting
    • Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
    • Contact: MADJID BOUKANTAR, MD; Phone Number: +33149812111; Email: madjid.boukantar@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stentys Xposition S Self-Apposing stent; STENTYS Xposition S Sirolimus Eluting Self-Apposing Coronary Stent System	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
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
strut malapposition at six months measured by OCT	6 months after CTO-PCI

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: May 28, 2018
• First Submitted That Met QC Criteria: June 10, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 10, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Coronary artery disease; Percutaneous coronary intervention; Chronic total occlusion; Self-expandable stent
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: K171009J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No