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To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Intervention | Experimental | Device: False Lumen Embolization System Device: IMPEDE-FX RapidFill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| False Lumen Embolization System, IMPEDE-FX RapidFill | Device | Embolization of the false lumen of an aortic dissection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Delivery and implantation of the investigational product implant to the false lumen | Immediately after the intervention |
| Major adverse events | Incidence of device/procedure-related major adverse events | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality and dissection-related mortality | Incidence of all-cause mortality and dissection-related mortality | 2 years |
| Serious adverse events | Incidence of device/procedure-related serious adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Miller, M.S. | Contact | +1 408 649 5175 | p.miller@shapemem.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland City Hospital | Recruiting | Auckland | 1023 | New Zealand |
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| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 2 years |
| Change in false lumen thrombosis from baseline | Change in false lumen thrombosis from baseline | 2 years |
| Change in true lumen/aorta size ratio from baseline | Change in true lumen/aorta size ratio from baseline | 2 years |
| Change in aorta size from baseline | Change in aorta size from baseline | 2 years |
| Rate of dissection-related reinterventions | Rate of dissection-related reinterventions | 2 years |
| Waikato Hospital | Recruiting | Hamilton | 3204 | New Zealand |
|
| D000094683 |
| Acute Aortic Syndrome |
| D001018 | Aortic Diseases |