Clinical trial NCT04271033: MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carotid Artery Diseases
Keywords: Stenting
Lead sponsor: John Paul II Hospital, Krakow
Sponsor class: OTHER
Collaborators: name: Jagiellonian University
First posted: 2020-02-17
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm registry
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: MACNE (Major Adverse Cardiac and Neurological Events)
timeFrame: 12 months
Secondary outcomes:
measure: Procedural success
timeFrame: Within 48 hours from index procedure
measure: In-hospital MACNE (Major Adverse Cardiac and Neurological Events)
timeFrame: Within 48 hours from index procedure
measure: 30-day MACNE (Major Adverse Cardiac and Neurological Events)
timeFrame: 30 days
measure: Incidence of any periprocedural complications
timeFrame: Within 48 hours
measure: Functional MRI efficacy assessment.
timeFrame: Within 48 hours
measure: Diffusion Weighted MRI efficacy assessment.
timeFrame: Within 48 hours
measure: Intravascular Ultrasound Stent Evaluation
timeFrame: Periprocedural
measure: Ipsilateral Stroke incidence
timeFrame: From one month until one year after the procedure.
measure: Ipsilateral Stroke incidence
timeFrame: From one year until five years after the procedure.
measure: Any stroke incidence
timeFrame: Within five years from the procedure.
measure: Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel
timeFrame: Periprocedural
measure: Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel
timeFrame: Within 30 days after index procedure.
measure: Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel
timeFrame: One year after index procedure.
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Department of Cardiac and Vascular Diseases, The John Paul II Hospital
state: Maloplska
Study officials:
affiliation: Jagiellonian University
name: Piotr Musialek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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