STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Total Occlusion, Coronary Artery Disease

Intervention / Treatment
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* Device: Implantation of Stent (PCI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stentys Xposition S Self-Apposing stent<br>STENTYS Xposition S Sirolimus Eluting Self-Apposing Coronary Stent System | Device: Implantation of Stent (PCI)<br>* Treatment of CTO with Percutaneous Coronary Intervention (PCI) Patients are randomized to receive either self-expandable stent or balloon expandable stent<br>|
| Active Comparator: Conventional Balloon-expandable stent<br>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)<br>* Treatment of CTO with Percutaneous Coronary Intervention (PCI) Patients are randomized to receive either self-expandable stent or balloon expandable stent<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic total occlusion, Self-expandable stent, Percutaneous coronary intervention, Coronary artery disease