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

Contego Medical

Status: Completed

Conditions: Carotid Artery Stenoses

Treatments: Device: carotid artery stenting

Study type: Observational

Funder types: Industry

Identifiers

NCT02501148

CSP-1001

Details and patient eligibility

About

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

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

106 participants in 1 patient group

Carotid artery stenting

Description:

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

Treatment:

Device: carotid artery stenting