Clinical trial NCT03563989: STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion
Official title: STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion (SXS-CTO)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Total Occlusion
Coronary Artery Disease
Keywords: Chronic total occlusion
Self-expandable stent
Percutaneous coronary intervention
Coronary artery disease
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: strut malapposition at six months measured by OCT
timeFrame: 6 months after CTO-PCI
Secondary outcomes:
measure: percentage of uncovered struts
timeFrame: 6 months after CTO-PCI
measure: lumen diameter (mm)
timeFrame: 6 months after CTO-PCI
measure: Restenosis
timeFrame: 6 months after CTO-PCI
measure: Angina pectoris
timeFrame: 6 months after CTO-PCI
measure: Dyspnea
timeFrame: 6 months after CTO-PCI
measure: Mortality
timeFrame: 6 months after CTO-PCI
measure: Stroke
timeFrame: 6 months after CTO-PCI
measure: Stent thrombosis
timeFrame: 6 months after CTO-PCI
Other outcomes:
Locations:
city: Créteil
country: France
facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Study officials:
References: