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The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Participants assigned to the treatment arm will undergo an endovascular procedure using the Nectero EAST System to deliver the Stabilizer Infusion Solution directly inside the aneurysm. This is a one-time local delivery of the product. Following treatment, surveillance of their AAA will be conducted using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years. Intervention: Drug: Stabilizer |
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| Control Arm | No Intervention | Participants assigned to the control arm will undergo surveillance of their AAA using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nectero EAST System | Drug | Treated subjects will undergo an endovascular procedure with the Nectero EAST system and receive the Stabilizer Infusion Solution (drug) within 30 days of the study eligibility by CT scan as a one-time local delivery of the drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | The primary endpoint is the composite of all AAA-related death, rupture and repair (open-surgical, EVAR, or clinically indicated for repair as adjudicated by a committee of clinical experts blinded to the assigned arm). | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Growth | The growth over time in aneurysm diameter based on CT core laboratory readings. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlene Knape | Contact | 866-755-4744 | cknape@necteromedical.com | |
| Tracy Roberts | Contact | (303)3964603 | troberts@necteromedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Clair, MD | Vanderbilt University Medical Center | Principal Investigator |
| Grace Wang, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honor Health Scottsdale Shea Medical Center | Recruiting | Scottsdale | Arizona | 85258 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37330148 | Background | Cheng SWK, Eagleton M, Echeverri S, Munoz JG, Holden AH, Hill AA, Krievins D, Ramaiah V. A pilot study to evaluate a novel localized treatment to stabilize small- to medium-sized infrarenal abdominal aortic aneurysms. J Vasc Surg. 2023 Oct;78(4):929-935.e1. doi: 10.1016/j.jvs.2023.05.056. Epub 2023 Jun 15. |
| Label | URL |
|---|---|
| J Vasc Surg. Pilot Study | View source |
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Prospective, randomized, controlled trial comparing the efficacy of the treatment arm to the control arm.
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For this trial, neither the patient nor investigator will be blinded to the study group assignment. However, members of the Sponsor, the CT core laboratory and the various committees reviewing subject data, such as the Clinical Events Committee (CEC), will be blinded to the randomization and assignment arm for an individual subject under review.
| University of Colorado | Active, not recruiting | Aurora | Colorado | 80045 | United States |
| Medstar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| Prime Vascular Institute | Active, not recruiting | Delray Beach | Florida | 33446 | United States |
| Medical College of Georgia | Recruiting | Augusta | Georgia | 30912 | United States |
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| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
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| MaineMed Vascular Surgery | Not yet recruiting | Scarborough | Maine | 04074 | United States |
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| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| University of Massachusetts | Recruiting | Worcester | Massachusetts | 01655 | United States |
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| Beaumont Health | Recruiting | Royal Oak | Michigan | 48073 | United States |
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| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
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| Dartmouth Hitchcock Medical Center | Active, not recruiting | Lebanon | New Hampshire | 03766 | United States |
| University of Rochester | Recruiting | Rochester | New York | 14642 | United States |
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| Stony Brook Medicine | Not yet recruiting | Stony Brook | New York | 11794 | United States |
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| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| The Christ Hospital | Recruiting | Cincinnati | Ohio | 45219 | United States |
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| University Hospitals Cleveland | Recruiting | Cleveland | Ohio | 44106 | United States |
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| Cleveland Clinic | Active, not recruiting | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Ohio Health Riverside | Recruiting | Columbus | Ohio | 43214 | United States |
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| Oklahoma Heart Institute | Recruiting | Tulsa | Oklahoma | 74104 | United States |
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| Portland VA Medical Center | Recruiting | Portland | Oregon | 97239 | United States |
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| St. Luke's University Health Network | Recruiting | Bethlehem | Pennsylvania | 18015 | United States |
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| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Jefferson Clinical Research Institute | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15219 | United States |
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| Prisma Health | Recruiting | Greenville | South Carolina | 29605 | United States |
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| North Central Heart - A Division of Avera Heart Hospital | Recruiting | Sioux Falls | South Dakota | 57108 | United States |
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| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Houston Healthcare | Recruiting | Houston | Texas | 77004 | United States |
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| Baylor Scott & White Medical Center | Recruiting | Plano | Texas | 75093 | United States |
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| University of Utah Hospital | Recruiting | Salt Lake City | Utah | 84132 | United States |
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| Inova Fairfax Medical Campus Inova Health Systems | Recruiting | Fairfax | Virginia | 22031 | United States |
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| University of Washington at Harborview Medical Center | Recruiting | Seattle | Washington | 98104 | United States |
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| Bellin Memorial Hospital | Recruiting | Green Bay | Wisconsin | 54301 | United States |
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| Prince of Wales Private Hospital- POW Vascular Institute | Recruiting | Randwick | New South Wales | 2031 | Australia |
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| Auckland City Hospital | Recruiting | Auckland | 1023 | New Zealand |
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| 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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