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Trial record 34 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Carotid Stenosis"

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

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ClinicalTrials.gov Identifier: NCT03488199
Recruitment Status : Recruiting
First Posted : April 4, 2018
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

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

Condition or disease Intervention/treatment Phase
Patients With Aterosclerotic Carotid Stenosis Symptomatic Patients (Stenosis > 50%) Asymptomatic Patients (Stenosis ≥80%) Device: Stent Acculink ™ Device: CGuardTM™ Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus the Mesh Covered Stent (CGuard™) The SIBERIA Trial
Actual Study Start Date : September 11, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Active Comparator: Stent Acculink™ (RX ACCULINK CAROTID STENT SYSTEM)
50 Carotid stenting (RX ACCULINK CAROTID STENT SYSTEM)
Device: Stent Acculink ™
Carotid Artery Revascularization using Stents
Other Name: RX ACCULINK CAROTID STENT SYSTEM

Experimental: Stent CGuard™ (The CGuardTM Embolic Prevention System (EPS))
50 Carotid stenting (The CGuardTM Embolic Prevention System (EPS))
Device: CGuardTM™
Carotid Artery Revascularization using Stents
Other Name: The CGuardTM Embolic Prevention System (EPS)




Primary Outcome Measures :
  1. determination of ischemic lesions [ Time Frame: at 30-days ]
    New DW-MRI lesions post procedural their permanence at 30-days

  2. determination of ischemic lesions [ Time Frame: at 48 hours ]
    New DW-MRI lesions post procedural (48 hours)



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488199


Contacts
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Contact: Vladimir B Starodubtsev +79137262163 v_starodubtsev@meshalkin.ru

Locations
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Russian Federation
Andrey A. Karpenko Recruiting
Novosibirsk, Russian Federation
Contact: Anna Arkhipova    +79137759326    starodub@mail.ru   
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation

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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT03488199     History of Changes
Other Study ID Numbers: NRICP 9872
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carotid Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases