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| Name | Class |
|---|---|
| Symic Biomedical, Inc. | INDUSTRY |
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The purpose of this study is to compare balloon angioplasty plus SBCV against balloon angioplasty alone for treatment of stenosis within the femoropopliteal artery.
This first-in-human study will evaluate the safety and effectiveness of a novel adjunctive therapy, SBCV, used with balloon angioplasty as compared to balloon angioplasty plus a control agent (saline) when used for the treatment of stenosis within the femoropopliteal artery. Effectiveness will be measured by late lumen loss at 24 weeks post treatment as evaluated by an independent, blinded core lab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBCV | Experimental | SBCV is administered to the site immediately post balloon dilation. |
|
| Control | Placebo Comparator | Saline is used as a control and is delivered immediately post balloon dilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBCV | Other | SBCV is a single use, sterile product that acts as a localized physical barrier at the vascular wall. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | The composite of no all-cause perioperative (≤30 day) mortality and none of the following events at 24 weeks following treatment:
| through 24 weeks |
| Late Lumen Loss | LLL is defined as the difference between the minimum lumen diameter (MLD) immediately post-primary procedure and the MLD at follow-up as measured by an independent, blinded core lab. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Melbourne | New South Wales | 2050 | Australia | ||
| Royal North Shore Hospital |
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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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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Other | Saline is used as a control. |
|
| Sydney |
| New South Wales |
| 2065 |
| Australia |
| Gold Coast University Hospital | Southport | Queensland | 4215 | Australia |
| Flinders Medical Center | Adelaide | South Australia | 5043 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3181 | Australia |
| Sir Charles Gairdner Hospital | Perth | Western Australia | 6009 | Australia |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D017670 |
| Sodium Compounds |