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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date May 2018
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

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

Locations

Country Name City State
France Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR Créteil

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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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