A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and clinical performance of Paladin System in patients with carotid artery stenosis.

Official Title
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A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection

Conditions
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Carotid Artery Stenoses

Intervention / Treatment
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* Device: carotid artery stenting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented stenotic atherosclerotic lesion located at carotid bifurcation and / or proximal internal carotid artery (ICA) Subject is either (A) symptomatic within 6 months of procedure, with an ipsilateral carotid stenosis ≥ 50% by angiography, or (B) asymptomatic with carotid stenosis ≥ 70% by angiography Target lesion can be covered by a single stent of no more than 40 mm in length Target lesion reference vessel diameter (RVD) is 4.0 mm - 7.0mm Sufficient landing zone required for successful deployment of integrated embolic protection filter Willing to comply with all follow-up required study visits Provision of written informed consent before index procedure Exclusion Criteria: Life expectancy of less than one year An evolving, acute or recent stroke within 14 days of study evaluation Acute myocardial infarction within 72 hours before procedure Known sensitivity to contrast media that cannot be adequately controlled with pre-medication Subject has a total occlusion of target carotid artery Subject has a previously place stent in ipsilateral carotid artery Severe circumferential lesion calcification that may restrict full deployment of carotid stent Presence of filling defect or thrombus in target vessel Presence of string sign of target vessel Carotid (intracranial) stenosis located distal to target lesion Greater than 50% stenosis of common carotid artery proximal to target lesion. Known mobile plaque in aortic arch

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Carotid artery stenting<br>Symptomatic and asymptomatic subjects requiring carotid artery stenting, post-dilation performed using the Paladin System with integrated embolic protection | Device: carotid artery stenting<br>* Post-dilation of deployed self-expanding carotid stent with the Paladin Post-Dilation Balloon System with Integrated Embolic Protection<br>* Other names: Paladin Post-Dilation Balloon System with Integrated Embolic Protection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-related MAE |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Embolic protection, Carotid artery stenting