Carotid Artery Diseases
Conditions
Keywords
Stenting
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
Interventions
DEVICECarotid Artery Stenting
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.
Sponsors
Jagiellonian University
John Paul II Hospital, Krakow
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm registry
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACNE (Major Adverse Cardiac and Neurological Events) | 12 months | Death, Stroke, Myocardial Infarction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital MACNE (Major Adverse Cardiac and Neurological Events) | Within 48 hours from index procedure | Death, Stroke, Myocardial Infarction within index hospitalization |
| 30-day MACNE (Major Adverse Cardiac and Neurological Events) | 30 days | Death, Stroke, Myocardial Infarction within 30 days |
| Incidence of any periprocedural complications | Within 48 hours | Any periprocedural complications |
| Functional MRI efficacy assessment. | Within 48 hours | In case of fMRI evaluation, pre and postprocedural imaging. |
| Procedural success | Within 48 hours from index procedure | Successful stent delivery and deployment without complication |
| Intravascular Ultrasound Stent Evaluation | Periprocedural | In case of IVUS examination, postprocedural stent expansion, apposition and carotid plaque sequestration evaluation. |
| Ipsilateral Stroke incidence | From one month until one year 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. |
| Peak Systolic Velocity in Duplex Ultrasound evaluation in target vessel | Periprocedural | Peak-systolic and End-diastolic Velocities assessed with DUS peri-proceduraly. |
| Diffusion Weighted MRI efficacy assessment. | Within 48 hours | In case of DW-MRI evaluation, new ischemic lesions according to protocol criteria in postprocedural imaging. |
Countries
Poland
Contacts
Primary ContactPiotr Musialek, MD, PhD
Outcome results
None listed