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

Completed

• Conditions: Carotid Artery Stenoses
• Interventions: Device: carotid artery stenting

• Registration Number: NCT02501148
• Lead Sponsor: Contego Medical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-17
• Study Start: 2015-08
• Primary Completion: 2016-09
• Study Completion: 2016-10
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Device-related MAE	30 days

Trial Locations

Locations (5)

Sankt Gertrauden Krankenhaus; 🇩🇪 Berlin, Germany

Universitäts-Herzzentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

CardioVascular Centre Frankfurt; 🇩🇪 Frankfurt, Germany

Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH; 🇩🇪 Hamburg, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany