The SIBERIA Trial (Acculink™ Versus CGuard™)

Asymptomatic Patients (Stenosis =80%) Clinical Trial

— CAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03488199
• Other study ID #: NRICP 9872
• Status: Completed
• Phase: N/A
• Start date: September 11, 2017
• Est. completion date: March 9, 2021

Study information

• Verified date: September 2021
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 9, 2021
• Est. primary completion date: February 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Asymptomatic Patients (Stenosis =80%)
• Carotid Stenosis
• Constriction, Pathologic
• Patients With Aterosclerotic Carotid Stenosis
• Symptomatic Patients (Stenosis > 50%)

Intervention

Device:
• Stent Acculink ™
Carotid Artery Revascularization using Stents
• CGuardTM™
Carotid Artery Revascularization using Stents

Locations

Country	Name	City	State
Russian Federation	Andrey A. Karpenko	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determination of ischemic lesions	New DW-MRI lesions post procedural their permanence at 30-days	at 30-days
Primary	determination of ischemic lesions	New DW-MRI lesions post procedural (48 hours)	at 48 hours