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

Primary Purpose

Chronic Total Occlusion, Coronary Artery Disease

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Implantation of Stent (PCI)

About this trial

This is an interventional treatment trial for Chronic Total Occlusion focused on measuring Chronic total occlusion, Self-expandable stent, Percutaneous coronary intervention, Coronary artery disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDORRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stentys Xposition S Self-Apposing stent

Conventional Balloon-expandable stent

Arm Description

STENTYS Xposition S Sirolimus Eluting Self-Apposing Coronary Stent System

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

Outcomes

Primary Outcome Measures

strut malapposition at six months measured by OCT

Secondary Outcome Measures

percentage of uncovered struts

lumen diameter (mm)

Restenosis

Angina pectoris

Dyspnea

Mortality

Stroke

Stent thrombosis

Full Information

NCT ID

NCT03563989

First Posted

May 28, 2018

Last Updated

August 10, 2018

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT03563989

Brief Title

STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion

Acronym

SXS-CTO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 26, 2018 (Actual)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Total Occlusion, Coronary Artery Disease

Keywords

Chronic total occlusion, Self-expandable stent, Percutaneous coronary intervention, Coronary artery disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stentys Xposition S Self-Apposing stent

Arm Type

Experimental

Arm Description

STENTYS Xposition S Sirolimus Eluting Self-Apposing Coronary Stent System

Arm Title

Conventional Balloon-expandable stent

Arm Type

Active Comparator

Arm 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.

Intervention Type

Device

Intervention Name(s)

Implantation of Stent (PCI)

Intervention Description

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

Primary Outcome Measure Information:

Title

strut malapposition at six months measured by OCT

Time Frame

6 months after CTO-PCI

Secondary Outcome Measure Information:

Title

percentage of uncovered struts

Time Frame

6 months after CTO-PCI

Title

lumen diameter (mm)

Time Frame

6 months after CTO-PCI

Title

Restenosis

Time Frame

6 months after CTO-PCI

Title

Angina pectoris

Time Frame

6 months after CTO-PCI

Title

Dyspnea

Time Frame

6 months after CTO-PCI

Title

Mortality

Time Frame

6 months after CTO-PCI

Title

Stroke

Time Frame

6 months after CTO-PCI

Title

Stent thrombosis

Time Frame

6 months after CTO-PCI

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

City

Créteil

ZIP/Postal Code

94010

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

MADJID BOUKANTAR, MD

Phone

+33149812111

madjid.boukantar@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Learn more about this trial

STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion

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