The SIBERIA Trial (Acculink™ Versus CGuard™) (CAS)

Meshalkin Research Institute of Pathology of Circulation

Status: Completed

Conditions: Symptomatic Patients (Stenosis > 50%); Patients With Aterosclerotic Carotid Stenosis; Asymptomatic Patients (Stenosis ≥80%)

Treatments: Device: CGuardTM™; Device: Stent Acculink ™

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03488199

NRICP 9872

Details and patient eligibility

About

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

Full 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).

Enrollment: 100 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Consecutive patients 45-80 years old accepted for CAS following neurological consultation and qualification for the procedure according to center's routine practice.
2. More than 6-month life expectancy
3. Suitable clinical conditions for performing DW-MRI
4. Written Informed consent approved by the Ethics Committee
5. Subject agrees to all required follow-up procedures and visits

Exclusion Criteria:

1. Currently enrolled in another investigational device or drug study that has not completed the study or that clinically interferes with the current study endpoints
2. Recent surgical procedure within 30-days before or planned surgery within 30-days after the stenting procedure
3. Hepatic active disease (bilirubin> 35 mmol / l) or renal insufficiency (serum creatinine > 2.5 mg/dL or glomerular filtration rate <60 ml / min)
4. Recent evolving acute stroke within 30-days of study evaluation
5. Myocardial infarction within 72 hours prior to carotid stenting procedure (CPK-MB > 3 times normal)
6. Female patients of childbearing potential or known to be pregnant
7. Any known factor for potential stroke other than carotid stenosis, such as atrial fibrillation or atrial flutter (paroxysmal, permanent or persistent) or thrombophilia
8. Patient on VKA or new oral anticoagulants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Stent Acculink™ (RX ACCULINK CAROTID STENT SYSTEM)

Active Comparator group

Description:

50 Carotid stenting (RX ACCULINK CAROTID STENT SYSTEM)

Treatment:

Device: Stent Acculink ™

Stent CGuard™ (The CGuardTM Embolic Prevention System (EPS))

Experimental group

Description:

50 Carotid stenting (The CGuardTM Embolic Prevention System (EPS))

Treatment:

Device: CGuardTM™