MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization
- Conditions
- Carotid Artery Diseases
- Interventions
- Device: Carotid Artery Stenting
- Registration Number
- NCT04271033
- Lead Sponsor
- John Paul II Hospital, Krakow
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 550
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Carotid Artery Stenting Carotid Artery Stenting 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.
- Primary Outcome Measures
Name Time Method MACNE (Major Adverse Cardiac and Neurological Events) 12 months Death, Stroke, Myocardial Infarction.
- Secondary Outcome Measures
Name Time Method Incidence of any periprocedural complications Within 48 hours Any periprocedural complications
Procedural success Within 48 hours from index procedure Successful stent delivery and deployment without complication
In-hospital MACNE (Major Adverse Cardiac and Neurological Events) Within 48 hours from index procedure Death, Stroke, Myocardial Infarction within index hospitalization
Diffusion Weighted MRI efficacy assessment. Within 48 hours In case of DW-MRI evaluation, new ischemic lesions according to protocol criteria in postprocedural imaging.
Functional MRI efficacy assessment. Within 48 hours In case of fMRI evaluation, pre and postprocedural imaging.
Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel One year after index procedure. Peak-systolic and End-diastolic Velocities assessed with DUS one year after discharge.
30-day MACNE (Major Adverse Cardiac and Neurological Events) 30 days Death, Stroke, Myocardial Infarction within 30 days
Intravascular Ultrasound Stent Evaluation Periprocedural In case of IVUS examination, postprocedural stent expansion, apposition and carotid plaque sequestration evaluation.
Ipsilateral Stroke incidence From one year until five years after the procedure. Ischemic stoke at the site of index procedure.
Any stroke incidence Within five years from the procedure. Any stroke during study observational period.
Trial Locations
- Locations (1)
Department of Cardiac and Vascular Diseases, The John Paul II Hospital
🇵🇱Kraków, Maloplska, Poland