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Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Device: Aventus Thrombectomy System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrombectomy | Device | Use of Aventus Thrombectomy System to treat pulmonary embolism |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in RV/LV Ratio | Change in RV/LV Ratio per CTA | From Baseline to 48 hours |
| Major Adverse Event Rate | Composite of device related MAEs including death, major bleed, clinical deterioration, pulmonary vascular injury, and cardiac injury | From Index Procedure to 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Li, MD | University Hospitals | Principal Investigator |
| Saher Sabri, MD | MedStar Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honor Health | Scottsdale | Arizona | 85258 | United States | ||
| NorthBay Medical Center |
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| Fairfield |
| California |
| 94533 |
| United States |
| MemorialCare | Long Beach | California | 90806 | United States |
| El Camino Health | Mountain View | California | 94040 | United States |
| Sutter Health | Sacramento | California | 95816 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| Medstar | Washington D.C. | District of Columbia | 20010 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Alexian Brothers Medical Center | Elk Grove Village | Illinois | 60007 | United States |
| Ascension St. Vincent | Indianapolis | Indiana | 46260 | United States |
| Ochsner Health | New Orleans | Louisiana | 70121 | United States |
| McLaren Health Care | Bay City | Michigan | 48708 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Ascension Providence | Southfield | Michigan | 48075 | United States |
| CentraCare Heart and Vascular | Saint Cloud | Minnesota | 56303 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | United States |
| Ichan School of Medicine at Mount Sinai | New York | New York | 10019 | United States |
| University Hospitals | Cleveland | Ohio | 44106 | United States |
| OhioHealth Research Institute | Columbus | Ohio | 43214 | United States |
| ProMedica - Jobst Vascular | Toledo | Ohio | 43606 | United States |
| Ascension St. John | Tulsa | Oklahoma | 74006 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Centennial Medical Center (HCA) | Nashville | Tennessee | 37203 | United States |
| Ascension Seton | Austin | Texas | 78705 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 19, 2026 |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013923 | Thromboembolism |
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| ID | Term |
|---|---|
| D017131 | Thrombectomy |
| ID | Term |
|---|---|
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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