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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00006281 | Registry Identifier | Deutsches Register Klinischer Studien |
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The purpose of this study is to assess the deliverability, clinical utility, safety and effectiveness of the 250 mm length size offering of the LifeStent® Vascular Stent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LifeStent Vascular Stent | Experimental | This is a single arm study and all subjects receive PTA and implantation of one Life Stent Vascular Stent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LifeStent Vascular Stent | Device | PTA followed by implantation of the LifeStent Vascular Stent (stent length 250 mm) in the SFA or popliteal artery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Events (MAEs) | Occurence of death or target limb amputation or any target lesion revascularization/target vessel revascularization through 30 days post-index procedure. These events will be assessed by clinical evaluations. | 30 days |
| Stent performance | Stent deployment success; defined as a post-deployment stent length deviating <10% from pre-deployment stent length (determined by an independent core lab). Placement accuracy based upon a rating scale completed by the investigator at time of index procedure. | intra operative |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Events (MAEs) | Occurence of death, stroke, MI, emergent surgical revascularization of the target limb, significant distal embolization in target limb, target limb major amputation, and thrombosis of target vessel at 12 months post-index procedure. These events will be assessed by clinical evaluations. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Zeller, Prof. Dr. | University Heart Centre Freiburg, Bad Krozingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Heart Centre Freiburg | Bad Krozingen | 79189 | Germany | |||
| Gemeinschaftspraxis für Radiologie |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Target lesion/vessel revascularization |
TLR/TVR rate after 12 months post-index procedure. TLR/TVR will be assessed by clinical evaluations. |
| 1 year |
| Target lesion patency | Primary patency (PSVR<2.4) rate at 12 month post-index procedure (measured by DUS). Patency will be assessed by clinical evaluations. | 1 year |
| Berlin |
| 13347 |
| Germany |
| Fürst Stirum Klinik Bruchsal | Bruchsal | 76646 | Germany |
| RoMed Klinikum Rosenheim | Rosenheim | 83022 | Germany |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |