Carotid Artery Disease Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Poland
Department of Cardiac and Vascular Diseases, The John Paul II Hospital
RECRUITING
Krakow
Contact Information
Primary
Piotr Musialek, MD, PhD
p.musialek@szpitaljp2.krakow.pl
+48126142287
Time Frame
Start Date: 2015-09-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 550
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Jagiellonian University
Leads: John Paul II Hospital, Krakow

This content was sourced from clinicaltrials.gov

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