Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stent 1 | Experimental | Zilver® PTX Stent |
|
| Stent 2 | Experimental | Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating |
|
| Stent 3 | Experimental | Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zilver® Paclitaxel-Eluting Peripheral Stent | Device | Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent. |
| Measure | Description | Time Frame |
|---|---|---|
| The percent diameter stenosis within the study lesion evaluated by conventional angiography. | Percent diameter stenosis will be calculated by comparing the minimal lumen diameter to the average of the proximal and distal reference vessel diameters. | 6 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Zeller, Prof. Dr. med. | Universitäts Herzzentrum Freiburg - Bad Krozingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Hochsauerland | Arnsberg | 59759 | Germany | |||
| Universitäts Herzzentrum Freiburg - Bad Krozingen |
Not provided
Not provided
Not provided
Not provided
Not provided
| Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating | Device | Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent. |
|
| Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating | Device | Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent. |
|
| Bad Krozingen |
| 79189 |
| Germany |
| Krankenhaud Bucholz | Buchholz | 21244 | Germany |
| St. Josefskrankenhaus Heidelberg | Heidelberg | 69115 | Germany |
| Universitätsklinikum Jena | Jena | 07747 | Germany |
| SRH Klinikum Karlsbad- Langensteinbach GmbH | Karlsruhe | 76307 | Germany |
| Universitatsklinikum Leipzig AoR | Leipzig | 04103 | Germany |
| MEDINOS Kliniken des Landkreises Sonneberg GmbH | Sonneberg | 96515 | Germany |
| Marienhospital Stuttgart | Stuttgart | 70199 | Germany |
| Uniklinikum Würzburg | Würzburg | 70199 | Germany |
| Auckland City Hospital, New Zealand | Auckland | 1023 | New Zealand |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
Not provided
Not provided