MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization (PARADIGM-EXT)

John Paul II Hospital, Krakow

Status: Enrolling

Conditions: Carotid Artery Diseases

Treatments: Device: Carotid Artery Stenting

Study type: Interventional

Funder types: Other

Identifiers

NCT04271033

PARADIGM-EXTEND

Details and patient eligibility

About

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.

Full 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

Enrollment: 550 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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550 participants in 1 patient group

Carotid Artery Stenting

Experimental group

Description:

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.

Treatment:

Device: Carotid Artery Stenting