Chronic Total Occlusion, Coronary Artery Disease
Conditions
Keywords
Chronic total occlusion, Self-expandable stent, Percutaneous coronary intervention, Coronary artery disease
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.
Interventions
DEVICEImplantation of Stent (PCI)
Treatment of CTO with Percutaneous Coronary Intervention (PCI) Patients are randomized to receive either self-expandable stent or balloon expandable stent
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| strut malapposition at six months measured by OCT | 6 months after CTO-PCI |
Secondary
| Measure | Time frame |
|---|---|
| lumen diameter (mm) | 6 months after CTO-PCI |
| Restenosis | 6 months after CTO-PCI |
| Angina pectoris | 6 months after CTO-PCI |
| percentage of uncovered struts | 6 months after CTO-PCI |
| Mortality | 6 months after CTO-PCI |
| Stroke | 6 months after CTO-PCI |
| Stent thrombosis | 6 months after CTO-PCI |
| Dyspnea | 6 months after CTO-PCI |
Countries
France
Outcome results
None listed