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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carotid artery stenting | Symptomatic and asymptomatic subjects requiring carotid artery stenting, post-dilation performed using the Paladin System with integrated embolic protection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carotid artery stenting | Device | Post-dilation of deployed self-expanding carotid stent with the Paladin Post-Dilation Balloon System with Integrated Embolic Protection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device-related MAE | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Adults; either gender; requiring percutaneous intervention of an asymptomatic (> 70%) or symptomatic (>50%) internal carotid artery stenosis.
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Thomas Zeller, MD | Universitäts Herzzentrum Freiburg Bad-Krozingen | Principal Investigator |
| Prof. Horst Sievert, MD | CardioVascular Center, Sankt Katharinen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäts-Herzzentrum Bad Krozingen | Bad Krozingen | 79189 | Germany | |||
| Sankt Gertrauden Krankenhaus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30784647 | Background | 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. |
| Label | URL |
|---|---|
| Double Filtration During Carotid Artery Stenting Using a Novel Post-Dilation Balloon With Integrated Embolic Protection | View source |
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|
| Berlin |
| Germany |
| CardioVascular Centre Frankfurt | Frankfurt | Germany |
| Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH | Hamburg | Germany |
| Universitätsklinikum Leipzig | Leipzig | Germany |
| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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