Clinical trial NCT02501148: A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection
Official title: A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Artery Stenoses
Keywords: Embolic protection
Carotid artery stenting
Lead sponsor: Contego Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-17
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults; either gender; requiring percutaneous intervention of an asymptomatic (\> 70%) or symptomatic (\>50%) internal carotid artery stenosis.

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


Eligibility criteria: 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

Primary outcomes:
measure: Device-related MAE
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Bad Krozingen
city: Berlin
country: Germany
facility: Sankt Gertrauden Krankenhaus
city: Frankfurt
country: Germany
facility: CardioVascular Centre Frankfurt
city: Hamburg
country: Germany
facility: Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
Study officials:
affiliation: Universitäts Herzzentrum Freiburg Bad-Krozingen
name: Prof. Thomas Zeller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CardioVascular Center, Sankt Katharinen Hospital
name: Prof. Horst Sievert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.