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The purpose of the study is to evaluate the safety and effectiveness of the PTX-coating on the Formula PTX Balloon-Expandable Stent in treatment of renal artery stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group A | Experimental |
| |
| Study Group B | Experimental |
| |
| Study Group C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formula PTX Stent - Dose 1 | Device | Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Diameter Stenosis of the Treated Renal Artery | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Ostrava-Poruba | 70852 | Czechia | |||
| Institute for Clinical and Experimental Medicine |
| ID | Term |
|---|---|
| D012078 | Renal Artery Obstruction |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Formula PTX Stent - Dose 2 | Device | Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded. |
|
| Formula PTX Stent - Dose 3 | Device | Stenting of the renal artery with a PTX-coated stent (experimental) or uncoated stent (active comparator). Groups are blinded. |
|
| Prague |
| Czechia |
| Hopital Europeen Georges Pomidou | Paris | France |
| Herz-Zentrum Bad Krozingen | Bad Krozingen | 79189 | Germany |
| Krankenhaus Neu-Bethlehem | Göttingen | 37073 | Germany |
| Uniklinik Heidelberg | Heidelberg | Germany |
| Universitatsklinikum Leipzig AoR | Leipzig | 04103 | Germany |
| St. Bonifatius Hospital | Lingen | 49808 | Germany |
| Klinik Dr. Hancken im Elbe Klinikum Stade | Stade | 21682 | Germany |
| Royal Sussex County Hospital | Brighton | BN5BE | United Kingdom |
| Kent & Canterbury Hospital | Canterbury | CT1 3NG | United Kingdom |
| St. Mary's Hospital | London | W2 1NY | United Kingdom |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |