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This is an exploratory pilot study to evaluate the safety and clinical utility of retreatment with an investigational combination product called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | Use of the EAST System for the stabilization treatment of AAA. The device is delivered endovascularly and placed in the AAA sac to deliver the Stabilizer Infusion Solution. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nectero EAST System | Combination Product | Participants 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: technical success | Technical success as defined by successful insertion of the catheter and delivery of the Stabilizer Solution dose. | Up to 30 days |
| Safety: adverse events post-treatment | Treatment-related adverse events up to 30 days after retreatment with the Nectero EAST System. | Up to 30 days |
| Efficacy: aneurysm growth over time | Aneurysmal growth rate post-treatment over time as compared to the immediate pretreatment annual growth rate. The growth rate over time in aneurysm diameter will be based on CT core laboratory readings at 12- and 24-months post-treatment. | At 12 and 24 months post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlene Knape | Contact | 866-755-4744 | cknape@necterotx.com | |
| Tracy Roberts | Contact | 303--396-4603 | troberts@necterotx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Private Hospital- POW Vascular Institute | Recruiting | Randwick | New South Wales | 2031 | Australia |
| 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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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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Population diagnosed with abdominal aortic aneurysm ≤5.3 cm in males and ≤4.8 cm in females that have had a previous treatment with the Nectero EAST System.
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| Auckland City Hospital | Recruiting | Auckland | 1023 | New Zealand |
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