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| Name | Class |
|---|---|
| NAMSA | OTHER |
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To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted. |
|
| Control | Active Comparator | Control Arm: Subjects in the control arm will only have an EVAR device implanted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMPEDE-FX RapidFill Implants | Device | Filling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint : AAA Sac Regression at 1 year | The percentage of subjects showing regression, defined as sac volume reduction of ≥10% at 1 year (in comparison to the 30 day CT), and no AAA-related intervention through 1 year. | 1 year |
| Primary Safety Endpoint : Major Adverse Event (MAE) Rate through 30 days | Freedom from the following through 30 days post-index procedure:
| 30 days |
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Inclusion Criteria:
Exclusion Criteria:
General
Anatomical
EVAR/Procedural
Medical History/Conditions
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| Name | Affiliation | Role |
|---|---|---|
| Marc Schermerhorn, M.D. | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Honor Health |
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A prospective, multicenter, randomized, open-label trial.
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Subjects will be blinded to the treatment arm prior to the index procedure; after the procedure, they will be unblinded prior to discharge to prevent unintentional unblinding due to imaging
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| EndoVascular Aneurysm Repair | Procedure | Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent. |
|
|
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| USC Keck | Los Angeles | California | 90033 | United States |
| San Diego VA Medical Center | San Diego | California | 92161 | United States |
| Delray Medical Center | Delray Beach | Florida | 33484 | United States |
| Mt. Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Orlando Health | Orlando | Florida | 32806 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Maine Medical | Portland | Maine | 04102 | United States |
| Johns Hopkins | Baltimore | Maryland | 21205 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| VA Ann Arbor Healthcare | Ann Arbor | Michigan | 48105 | United States |
| Corewell Health | Grand Rapids | Michigan | 49503 | United States |
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| University at Buffalo | Buffalo | New York | 14203 | United States |
| Buffalo VA Western New York | Buffalo | New York | 14215 | United States |
| NYU Langone | New York | New York | 10016 | United States |
| Columbia University Irving Medical Center/New York Presbyterian Hospital | New York | New York | 10032 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Stony Brook Medicine | Stony Brook | New York | 11794 | United States |
| TriHealth Heart Institute | Cincinnati | Ohio | 45242 | United States |
| Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| The Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Sanford Health | Sioux Falls | South Dakota | 57105 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| St. David's Healthcare | Austin | Texas | 78705 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |
| Baylor Scott and White | Plano | Texas | 75093 | United States |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Inova Schar Heart and Vascular | Falls Church | Virginia | 22042 | United States |
| Sentara Norfolk General | Norfolk | Virginia | 23507 | United States |
| University of Wisconsin | Madison | Wisconsin | 53715 | United States |
| Hopital Cardiologie | Lille | Hauts-de-France | 59037 | France |
| Marie Lannelongue Hospital | Paris | Le Plessis-Robinson | 92350, | France |
| Rijnstate Hospital | Arnhem | Gelderland | 6800 TA | Netherlands |
| ETZ Elisabeth | Tilburg | Tilburg | 5022 GC | Netherlands |
| Amsterdam UMC | Amsterdam | Netherlands |
| Erasmus Medical Center | Rotterdam | 3015 GD | Netherlands |
| Auckland City Hospital | Auckland | Auckland | 1023 | New Zealand |
| Waikato Hospital | Hamilton | 3204 | New Zealand |
| St Georges University Hospitals NHS Foundation Trust | London | SW17 0GT | United Kingdom |
| St. Marys Hospital | London | W21 1NY | United Kingdom |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| ID | Term |
|---|---|
| D000094682 | Endovascular Aneurysm Repair |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019917 | Blood Vessel Prosthesis Implantation |
| D058017 | Vascular Grafting |
| D019060 | Minimally Invasive Surgical Procedures |
| D019919 | Prosthesis Implantation |
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