Using a MicroNet-covered stent to prevent strokes in patients needing carotid artery treatment
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
This study is testing a new type of stent to see if it can help prevent strokes in patients who need treatment for narrowed carotid arteries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 550 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | John Paul II Hospital, Krakow Academic / other |
| Locations | 1 site (Krakow, Maloplska) |
| Trial ID | NCT04271033 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility, efficacy, and safety of the MicroNet-covered stent system (CGuard™) for carotid artery revascularization in a diverse group of patients. It is an independent, multicenter, open-label trial that includes both symptomatic patients and asymptomatic patients at increased risk of stroke. The study aims to assess the periprocedural outcomes and long-term safety of this novel stent system in treating carotid artery stenosis. Patients will be monitored through clinical and ultrasonographic follow-ups to gather comprehensive data on the stent's performance.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with symptomatic or high-risk asymptomatic carotid stenosis requiring revascularization.
Not a fit: Patients who do not qualify for carotid revascularization or have a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of stroke in patients undergoing carotid artery revascularization.
How similar studies have performed: Other studies have shown promising results with similar stenting approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / 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)
Where this trial is running
Krakow, Maloplska
- Department of Cardiac and Vascular Diseases, The John Paul II Hospital — Krakow, Maloplska, Poland (Recruiting)
Study contacts
- Principal investigator: Piotr Musialek, MD, PhD — Jagiellonian University
- Study coordinator: Piotr Musialek, MD, PhD
- Email: p.musialek@szpitaljp2.krakow.pl
- Phone: +48126142287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.