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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


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
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




Primary Outcome Measures :
  1. strut malapposition at six months measured by OCT [ Time Frame: 6 months after CTO-PCI ]

Secondary Outcome Measures :
  1. percentage of uncovered struts [ Time Frame: 6 months after CTO-PCI ]
  2. lumen diameter (mm) [ Time Frame: 6 months after CTO-PCI ]
  3. Restenosis [ Time Frame: 6 months after CTO-PCI ]
  4. Angina pectoris [ Time Frame: 6 months after CTO-PCI ]
  5. Dyspnea [ Time Frame: 6 months after CTO-PCI ]
  6. Mortality [ Time Frame: 6 months after CTO-PCI ]
  7. Stroke [ Time Frame: 6 months after CTO-PCI ]
  8. 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
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

Information from the National Library of Medicine

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


Locations
France
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR Recruiting
Créteil, France, 94010
Contact: MADJID BOUKANTAR, MD    +33149812111    madjid.boukantar@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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