Clinical trial NCT05257161: Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS
Official title: Independent Randomized Clinical Trial in Carotid Revascularization With MicroNet Covered Stent (CGuard) Comparing Early Neurological Outcomes With Distal EPS Versus Proximal EPS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patients With Aterosclerotic Carotid Stenosis
Symptomatic Patients (Stenosis > 50%)
Asymptomatic Patients (Stenosis ≥80%)
Keywords: Carotid artery stenting. CGuard stent. Protection Device.
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
Collaborators: name: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
name: Chelyabinsk Regional Clinical Hospital
First posted: 2022-02-25
Enrollment: 366
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The SIBERIA study demonstrated a clear advantage of CGuard stent implantation over the existing classical stent when using a distal anti-embolic device. At the same time, there is no Level 1 evidence for a difference between the proximal and distal anti-embolic device for the CGuard stent.


Eligibility 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

Primary outcomes:
measure: determination of ischemic lesions
timeFrame: 24-48 hours
Secondary outcomes:
measure: MACCE
timeFrame: Intraoperatively, and within 48 hours.
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: E. Meshalkin National Medical Research Center
Study officials:
References:
citation: Montorsi P, Caputi L, Galli S, Ravagnani PM, Teruzzi G, Annoni A, Calligaris G, Fabbiocchi F, Trabattoni D, de Martini S, Grancini L, Pontone G, Andreini D, Troiano S, Restelli D, Bartorelli AL. Carotid Wallstent Versus Roadsaver Stent and Distal Versus Proximal Protection on Cerebral Microembolization During Carotid Artery Stenting. JACC Cardiovasc Interv. 2020 Feb 24;13(4):403-414. doi: 10.1016/j.jcin.2019.09.007. Epub 2020 Jan 29.