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

Carotid Artery Stenoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501148
• Other study ID #: CSP-1001
• Status: Completed
• Start date: August 2015
• Est. completion date: October 2016

Study information

• Verified date: November 2022
• Source: Contego Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Artery Stenoses
• Carotid Stenosis

Intervention

Device:
• carotid artery stenting
Post-dilation of deployed self-expanding carotid stent with the Paladin Post-Dilation Balloon System with Integrated Embolic Protection

Locations

Country	Name	City	State
Germany	Universitäts-Herzzentrum Bad Krozingen	Bad Krozingen
Germany	Sankt Gertrauden Krankenhaus	Berlin
Germany	CardioVascular Centre Frankfurt	Frankfurt
Germany	Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH	Hamburg
Germany	Universitätsklinikum Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Contego Medical, Inc.

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Langhoff R, Schofer J, Scheinert D, Schmidt A, Sedgewick G, Saylors E, Sachar R, Sievert H, Zeller T. Double Filtration During Carotid Artery Stenting Using a Novel Post-Dilation Balloon With Integrated Embolic Protection. JACC Cardiovasc Interv. 2019 Feb 25;12(4):395-403. doi: 10.1016/j.jcin.2018.11.039. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device-related MAE		30 days

External Links

•   Double Filtration During Carotid Artery Stenting Using a Novel Post-Dilation Balloon With Integrated Embolic Protection