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

Study Overview
=================
Brief 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.

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

Official Title
-----------------
Long-term Outcomes of MicroNet-covered Stent Routine Use for Stroke Prevention in Symptomatic and Increased-risk Asymptomatic Carotid Stenosis Patients Requiring Revascularization by Neurovascular Team Decision: PARADIGM-EXTEND

Conditions
-----------------
Carotid Artery Diseases

Intervention / Treatment
-----------------
* Device: Carotid Artery Stenting


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm registry
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carotid Artery Stenting<br>Consecutive male and female patients older than 18 year with symptomatic and increased-stroke-risk asymptomatic carotid lesions that require revascularization by Neurovascular Team decision. | Device: Carotid Artery Stenting<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACNE (Major Adverse Cardiac and Neurological Events) | Death, Stroke, Myocardial Infarction. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | Successful stent delivery and deployment without complication | Within 48 hours from index procedure | 
| In-hospital MACNE (Major Adverse Cardiac and Neurological Events) | Death, Stroke, Myocardial Infarction within index hospitalization | Within 48 hours from index procedure | 
| 30-day MACNE (Major Adverse Cardiac and Neurological Events) | Death, Stroke, Myocardial Infarction within 30 days | 30 days | 
| Incidence of any periprocedural complications | Any periprocedural complications | Within 48 hours | 
| Functional MRI efficacy assessment. | In case of fMRI evaluation, pre and postprocedural imaging. | Within 48 hours | 
| Diffusion Weighted MRI efficacy assessment. | In case of DW-MRI evaluation, new ischemic lesions according to protocol criteria in postprocedural imaging. | Within 48 hours | 
| Intravascular Ultrasound Stent Evaluation | In case of IVUS examination, postprocedural stent expansion, apposition and carotid plaque sequestration evaluation. | Periprocedural | 
| Ipsilateral Stroke incidence | Ischemic stoke at the site of index procedure. | From one month until one year after the procedure. | 
| Ipsilateral Stroke incidence | Ischemic stoke at the site of index procedure. | From one year until five years after the procedure. | 
| Any stroke incidence | Any stroke during study observational period. | Within five years from the procedure. | 
| Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel | Peak-systolic and End-diastolic Velocities assessed with DUS peri-proceduraly. | Periprocedural | 
| Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel | Peak-systolic and End-diastolic Velocities assessed with DUS 30 day after discharge. | Within 30 days after index procedure. | 
| Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel | Peak-systolic and End-diastolic Velocities assessed with DUS one year after discharge. | One year after index procedure. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stenting