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

John Paul II Hospital, Krakow550 enrolled

Overview

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.

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. The multicenter arm of the project has a specific cohort descriptor: PARADIGM-EXTEND MC

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

550

Conditions

Carotid Artery Diseases

Interventions

Carotid Artery StentingDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

General 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 General 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)

Locations (1)

Department of Cardiac and Vascular Diseases, The John Paul II Hospital

Krakow, Maloplska, Poland

RECRUITING

Outcomes

Primary Outcomes

MACNE (Major Adverse Cardiac and Neurological Events)

Death, Stroke, Myocardial Infarction.

Time frame: 12 months

Secondary Outcomes

Procedural success

Successful stent delivery and deployment without complication

Time frame: Within 48 hours from index procedure

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

Death, Stroke, Myocardial Infarction within index hospitalization

Time frame: Within 48 hours from index procedure

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

Death, Stroke, Myocardial Infarction within 30 days

Time frame: 30 days

Incidence of any periprocedural complications

Any periprocedural complications

Time frame: Within 48 hours

Functional MRI efficacy assessment.

In case of fMRI evaluation, pre and postprocedural imaging.

Time frame: Within 48 hours

Diffusion Weighted MRI efficacy assessment.

In case of DW-MRI evaluation, new ischemic lesions according to protocol criteria in postprocedural imaging.

Time frame: Within 48 hours

Intravascular Ultrasound Stent Evaluation

In case of IVUS examination, postprocedural stent expansion, apposition and carotid plaque sequestration evaluation.

Central Contacts

Piotr Musialek, MD, PhD

CONTACT

+48126142287 p.musialek@szpitaljp2.krakow.pl

Data from ClinicalTrials.gov

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