MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohn Paul II Hospital, Krakow

About this trial

All-comer study of unselected patients suitable for carotid artery revascularization to evaluate the feasibility, efficacy and safety of first line endovascular revasculariztion using MicroNet covered stent (CGuard™) in the treatment of consecutive symptomatic and increased-stroke-risk asymptomatic carotid lesions that require revascularization by Neurovascular Team decision.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient > 18 years old qualified by NeuroVascular Team for carotid revascularization according to local standards of care

Signed informed consent

Agreement (routin un this group of patients) to clinical and ultrasonographis follow up.

De-novo atherosclerotic lesions or neo-atherosclerosis

Disqualifiers

Lack of NeuroVascular Team agreement on carotid revascularization indication

Lack of signed informed consent

Estimated life expectancy less than 1 year

Chronic renal failure with serum creatinine level > 3.0 mg/dL

Trial design

Design model

Single group

Treatments tested in this trial

  • Carotid Artery Stenting

    Device

    Carotid artery stenting according to local clinical experience and ESC/ESVS guidelines using exclusively CGuard™, MicroNet covered stent under proximal or distal intraprocedural cerebral protection according to "tailored CAS" algorithm.

Treatment groups

550 Participants
are divided into 1 treatment group
Group A: Carotid Artery StentingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

MACNE (Major Adverse Cardiac and Neurological Events)

Death, Stroke, Myocardial Infarction.

Time frame
12 months

Secondary outcomes

1

Procedural success

Successful stent delivery and deployment without complication

Time frame
Within 48 hours from index procedure
2

In-hospital MACNE (Major Adverse Cardiac and Neurological Events)

Death, Stroke, Myocardial Infarction within index hospitalization

Time frame
Within 48 hours from index procedure
3

30-day MACNE (Major Adverse Cardiac and Neurological Events)

Death, Stroke, Myocardial Infarction within 30 days

Time frame
30 days
4

Incidence of any periprocedural complications

Any periprocedural complications

Time frame
Within 48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

John Paul II Hospital, Krakow

Lead sponsor

Jagiellonian University

Collaborator