The SIBERIA Trial (Acculink™ Versus CGuard™)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-11

Study Completion Date

2021-03-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS

NCT05257161

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

RECRUITING NA

The REALITY Study - Head-to-Head Comparison Between Cypher and Taxus

NCT00235092

Coronary Artery Disease

COMPLETED PHASE4

Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting

NCT04900844

Carotid Artery Stenosis

ACTIVE_NOT_RECRUITING NA

CHOICE: Carotid Stenting For High Surgical-Risk Patients

NCT00406055

Carotid Artery Disease

COMPLETED

Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study)

NCT00287508

Carotid Artery Disease Carotid Stenosis Stroke +1 more

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stent Acculink™ (RX ACCULINK CAROTID STENT SYSTEM)

50 Carotid stenting (RX ACCULINK CAROTID STENT SYSTEM)

Group Type ACTIVE_COMPARATOR

Stent Acculink ™

Intervention Type DEVICE

Carotid Artery Revascularization using Stents

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

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

Group Type EXPERIMENTAL

CGuardTM™

Intervention Type DEVICE

Carotid Artery Revascularization using Stents

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stent Acculink ™

Carotid Artery Revascularization using Stents

Intervention Type DEVICE

CGuardTM™

Carotid Artery Revascularization using Stents

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RX ACCULINK CAROTID STENT SYSTEM The CGuardTM Embolic Prevention System (EPS)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No