The SIBERIA Trial (Acculink™ Versus CGuard™)

NCT03488199 | Completed

• 1 other identifier: NRICP 9872
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• determination of ischemic lesions

  New DW-MRI lesions post procedural their permanence at 30-days

  at 30-days

• determination of ischemic lesions

  New DW-MRI lesions post procedural (48 hours)

  at 48 hours

Study Arms (2)

Stent Acculink™ (RX ACCULINK CAROTID STENT SYSTEM)

ACTIVE COMPARATOR

50 Carotid stenting (RX ACCULINK CAROTID STENT SYSTEM)

Device: Stent Acculink ™

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

EXPERIMENTAL

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

Device: CGuardTM™

Interventions

Stent Acculink ™ DEVICE

Carotid Artery Revascularization using Stents

Also known as: RX ACCULINK CAROTID STENT SYSTEM

Stent Acculink™ (RX ACCULINK CAROTID STENT SYSTEM)

CGuardTM™ DEVICE

Carotid Artery Revascularization using Stents

Also known as: The CGuardTM Embolic Prevention System (EPS)

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

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

Andrey A. Karpenko

Novosibirsk, Russia

Location

Related Publications (1)

• Karpenko A, Bugurov S, Ignatenko P, Starodubtsev V, Popova I, Malinowski K, Musialek P. Randomized Controlled Trial of Conventional Versus MicroNet-Covered Stent in Carotid Artery Revascularization. JACC Cardiovasc Interv. 2021 Nov 8;14(21):2377-2387. doi: 10.1016/j.jcin.2021.08.005.

  PMID: 34736737 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: April 4, 2018
• Study Start: September 11, 2017
• Primary Completion: February 11, 2021
• Study Completion: March 9, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-09

Locations

RU (1)