STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion (SXS-CTO)
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ClinicalTrials.gov Identifier: NCT03563989 |
Recruitment Status :
Recruiting
First Posted : June 20, 2018
Last Update Posted : August 13, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Total Occlusion Coronary Artery Disease | Device: Implantation of Stent (PCI) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion (SXS-CTO) |
Actual Study Start Date : | June 26, 2018 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | December 2019 |
Arm | Intervention/treatment |
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Experimental: Stentys Xposition S Self-Apposing stent
STENTYS Xposition S Sirolimus Eluting Self-Apposing Coronary Stent System
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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.
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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 |
- strut malapposition at six months measured by OCT [ Time Frame: 6 months after CTO-PCI ]
- percentage of uncovered struts [ Time Frame: 6 months after CTO-PCI ]
- lumen diameter (mm) [ Time Frame: 6 months after CTO-PCI ]
- Restenosis [ Time Frame: 6 months after CTO-PCI ]
- Angina pectoris [ Time Frame: 6 months after CTO-PCI ]
- Dyspnea [ Time Frame: 6 months after CTO-PCI ]
- Mortality [ Time Frame: 6 months after CTO-PCI ]
- Stroke [ Time Frame: 6 months after CTO-PCI ]
- Stent thrombosis [ Time Frame: 6 months after CTO-PCI ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563989
France | |
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR | Recruiting |
Créteil, France, 94010 | |
Contact: MADJID BOUKANTAR, MD +33149812111 madjid.boukantar@aphp.fr |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT03563989 History of Changes |
Other Study ID Numbers: |
K171009J |
First Posted: | June 20, 2018 Key Record Dates |
Last Update Posted: | August 13, 2018 |
Last Verified: | May 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Chronic total occlusion Self-expandable stent Percutaneous coronary intervention Coronary artery disease |
Additional relevant MeSH terms:
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |