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This study is a post-market, prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artix Thrombectomy System | Experimental | Non-surgical removal of lower extremity arterial emboli and thrombi using the Artix Thrombectomy System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artix Thrombectomy System | Device | Treatment of lower extremity arterial occlusions using the Artix Thrombectomy System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint | Revascularization rate post-index procedure of target treatment area determined by an independent core lab. | Immediately Following Index Procedure |
| Primary Safety Endpoint | Periprocedural (within 48 hours) Artix Thrombectomy System-related major bleeding rate adjudicated as causal to the study device as determined by an independent Medical Monitor. | 48 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Distal embolization SAEs | Intra-procedure | |
| All-cause mortality | 1-month follow-up visit | |
| Limb salvage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Allen | Contact | 651-279-8587 | james.allen2@stryker.com | |
| Chris Ottaviano | Contact | 609-634-4571 | chris.ottaviano@stryker.com |
| Name | Affiliation | Role |
|---|---|---|
| Scott T Lewis | Inari Medical | Study Director |
| Anahita Dua, MD | Massachusetts General Hospital | Principal Investigator |
| Shang Loh, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | Recruiting | New Haven | Connecticut | 06510 | United States |
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Freedom from major amputation of the index limb
| 1-month follow-up visit |
| Amputation-free survival | Freedom from major amputation and all-cause mortality | 1-month follow-up visit |
| Penn Presbyterian Medical Center |
| Principal Investigator |
| MedStar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| Mass General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| MyMichigan Health | Recruiting | Midland | Michigan | 48670 | United States |
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| Cooper University Hospital | Recruiting | Camden | New Jersey | 08103 | United States |
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| Mission Memorial Hospital | Recruiting | Asheville | North Carolina | 28801 | United States |
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| Aultman Hospital | Recruiting | Canton | Ohio | 44710 | United States |
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| The Christ Hospital | Recruiting | Cincinnati | Ohio | 45219 | United States |
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| Ascension St. John Jane Phillips Medical Center | Recruiting | Bartlesville | Oklahoma | 74006 | United States |
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| Saint Francis Hospital | Recruiting | Tulsa | Oklahoma | 74136 | United States |
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| Allegheny General Hospital | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
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| Grand Strand Medical Center | Recruiting | Myrtle Beach | South Carolina | 29572 | United States |
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| TriStar Centennial Medical Center | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Bellin Health | Recruiting | Green Bay | Wisconsin | 54301 | United States |
|