NCT03488199

The SIBERIA Trial (Acculink™ Versus CGuard™)

Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus the Mesh Covered Stent (CGuard™) The SIBERIA Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

That the study will be carried out as it has the protocol instructions, respecting the applicable regulations for clinical investigations with medical devices and following the internationally accepted ethical standards

Detailed description

Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus the Mesh Covered Stent (CGuard™) was performed. Ischemic lesions of brain after CAS were determined by MRI before and after treatment (2-3 days, 1 month).

Conditions

• Patients With Aterosclerotic Carotid Stenosis
• Symptomatic Patients (Stenosis > 50%)
• Asymptomatic Patients (Stenosis ≥80%)

Interventions

Type	Name	Description
DEVICE	Stent Acculink ™	Carotid Artery Revascularization using Stents
DEVICE	CGuardTM™	Carotid Artery Revascularization using Stents

Timeline

• Start date: 2017-09-11
• Primary completion: 2021-02-11
• Completion: 2021-03-09
• First posted: 2018-04-04
• Last updated: 2021-10-08

Locations

1 site across 1 country: Russia