Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
| B. Braun Melsungen AG | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Patients with peripheral artery disease will be treated with either drug coated balloon catheter, drug coated stent or uncoated stent.
Patients with chronic stenotic or occlusive atherosclerotic disease and lesions of at least 13 cm length in the SFA or Arteria poplitea segment 1 will be randomized to either treatment with paclitaxel coated balloon catheter, paclitaxel coated stent or bare nitinol stent. Vessel patency will be evaluated by quantitative angiography after 12 months. Clinical follow-ups will be done until 36 months post-intervention.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug coated balloon catheter | Experimental | PTA with paclitaxel coated "SeQuent Please OTW" |
|
| Drug coated stent | Active Comparator | PTA with paclitaxel coated "Eluvia Vascular Stent System" |
|
| Uncoated stent | Active Comparator | PTA with bare nitinol stent (as commonly used in site) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SeQuent Please OTW | Device | Dilatation of occluded or highly stenosed vessel with paclitaxel-coated balloon catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent diameter stenosis at 1 year post intervention in successfully treated patients | by quantitative angiography | 12 +/- 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Late Lumen Loss | by quantitative angiography | 12 months |
| Binary restenosis | by DUS | 6,12, 24, 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | absence from target lesion revascularization, amputations and death | 6, 12, 24, 36 months |
| Walking distance | assessed in m and compared to baseline value |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gunnar Tepe, MD | RoMed Klinikum Rosenheim | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Graz | Graz | Austria | ||||
| RoMed Klinikum |
Not provided
| ID | Term |
|---|---|
| D003251 | Constriction, Pathologic |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
Vessel patency will be compared by quantitative angiography at 12 months in patients who have been treated either with paclitaxel coated balloon catheter, paclitaxel coated stent or bare metal stent in femoropopliteal arteries
Not provided
Not provided
Corelab will be masked for the bare metal and paclitaxel coated stent arm.
Not provided
| Eluvia Vascular Stent System | Device | Dilatation of occluded or highly stenosed vessel with paclitaxel-coated stent |
|
| Nitinol stent | Device | Dilatation of occluded or highly stenosed vessel with uncoated bare nitinol stent |
|
| Target lesion revascularization | number of re-interventions at target lesion | 6, 12, 24, 36 months |
| 6, 12, 24, 36 months |
| Rosenheim |
| Bavaria |
| Germany |
| Klinikum Arnsberg, Karolinen-Hospital | Arnsberg | Germany |
| Herzzentrum Bad Krozingen | Bad Krozingen | Germany |
| Ihre-Radiologen Standort Franziskus-Krankenhaus | Berlin | Germany |
| Ihre-Radiologen Standort Jüdisches Krankenhaus | Berlin | Germany |
| Vivantes Klinikum Neukölln | Berlin | Germany |
| Diakonissenkrankenhaus Flensburg | Flensburg | Germany |
| SANA Kliniken Lübeck | Lübeck | Germany |
| Universitätklinikum Lübeck | Lübeck | Germany |
| D014947 | Wounds and Injuries |