Carotid Artery Stenoses
Conditions
Keywords
Embolic protection, Carotid artery stenting
Brief summary
The purpose of this study is to assess the safety and clinical performance of Paladin System in patients with carotid artery stenosis.
Interventions
DEVICEcarotid artery stenting
Post-dilation of deployed self-expanding carotid stent with the Paladin Post-Dilation Balloon System with Integrated Embolic Protection
Sponsors
Contego Medical, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device-related MAE | 30 days |
Countries
Germany
Outcome results
None listed