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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-10-31

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.

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Detailed Description

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Conditions

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Carotid Artery Stenoses

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Carotid artery stenting

Symptomatic and asymptomatic subjects requiring carotid artery stenting, post-dilation performed using the Paladin System with integrated embolic protection

carotid artery stenting

Intervention Type DEVICE

Post-dilation of deployed self-expanding carotid stent with the Paladin Post-Dilation Balloon System with Integrated Embolic Protection

Interventions

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carotid artery stenting

Post-dilation of deployed self-expanding carotid stent with the Paladin Post-Dilation Balloon System with Integrated Embolic Protection

Intervention Type DEVICE

Other Intervention Names

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Paladin Post-Dilation Balloon System with Integrated Embolic Protection

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No