Coronary Artery Disease Clinical Trial
— SXS-CTOOfficial title:
STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion (SXS-CTO)
NCT number | NCT03563989 |
Other study ID # | K171009J |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 26, 2018 |
Est. completion date | December 2019 |
Verified date | May 2018 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR | Créteil |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | strut malapposition at six months measured by OCT | 6 months after CTO-PCI | ||
Secondary | percentage of uncovered struts | 6 months after CTO-PCI | ||
Secondary | lumen diameter (mm) | 6 months after CTO-PCI | ||
Secondary | Restenosis | 6 months after CTO-PCI | ||
Secondary | Angina pectoris | 6 months after CTO-PCI | ||
Secondary | Dyspnea | 6 months after CTO-PCI | ||
Secondary | Mortality | 6 months after CTO-PCI | ||
Secondary | Stroke | 6 months after CTO-PCI | ||
Secondary | Stent thrombosis | 6 months after CTO-PCI |
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