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

  • STATUS
    Recruiting
  • End date
    Jun 23, 2026
  • participants needed
    550
  • sponsor
    John Paul II Hospital, Krakow
Updated on 23 January 2021
atherosclerosis
angiography
stenosis
stroke
amaurosis fugax
ischemic attack
carotid revascularization

Summary

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.

Description

Independent investigator initiated, academic, single arm, open-label, non-randomized, prospective, multicenter, multispecialty trial of CGuard routine use in all-comer population of consecutive patients with symptomatic or increased-stroke-risk asymptomatic carotid stenosis.

Increased-stroke-risk is defined as the following patient and/or lesion characteristics:

thrombus containing, documented progressive, irregular, ulcerated lesion; evidence of ipsilateral ischemic cerebral injury in MRI or CT imaging; contralateral stroke in relation to carotid stenosis; contralateral artery occlusion.

The main objective of this observational study is to evaluate (1) the periprocedural feasibility and efficacy of CGuard stent system in the treatment of carotid artery stenosis (2) long-term efficacy and safety of routine CGuard stent system use.

The study hypothesis is that the novel CGuard MicroNet covered stent is safe and effective for a majority of consecutive patients considered to require carotid revascularization.

Details
Condition CAROTID ARTERY DISEASE
Treatment Carotid Artery Stenting
Clinical Study IdentifierNCT04271033
SponsorJohn Paul II Hospital, Krakow
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Angiographic Inclusion Criteria
De-novo atherosclerotic lesions or neo-atherosclerosis
Symptomatic patients (history of transient ischemic attack, ischaemic stroke or amaurosis fugax within 6 months from index procedure) with index artery stenosis 50% assessed in angiography with NASCET method or
Asymptomatic patients with index artery stenosis 70-80% assessed in angiography with NASCET method

Exclusion Criteria

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
Myocardial Infarction within 72 hours prior to index procedure
Pregnant women
Diagnosed coagulopathies
History of contrast media allergy, not reacting to pharmacotherapy
Angiographic Exclusion Criteria
Index lesion occlusion
Common carotid artery stent protruding to aortic arch
Anatomical conditions restricting stent implantation
Significant common carotid artery stenosis proximal to index lesion (unless treated)
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