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This is a first in human study to evaluate the safety and clinical utility of an investigational medical device called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA.
This is a Phase I multi-center, open-label study to evaluate use of the Nectero EAST system for stabilization of abdominal aortic aneurysms. Up to fifty (50) subjects will be treated at up to 10 worldwide sites with the device and followed for up to 36-months.
Primary Study Endpoints:
Secondary Study Endpoints:
Study duration is anticipated to be 6 years.
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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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Aneurysm Stabilization Treatment (EAST) | Device | Endovascular procedure: an ipsilateral ilio-femoral aortogram to confirm suitability for placement of a 14F sheath will be performed. A baseline contrast aortogram will be performed to assess vessel patency and target location of the EAST delivery catheter. Occluding and Stabilizer balloons are inflated in preparation for Stabilizer Compound delivery within the AAA sac. A post-Stabilizer angiogram will re-assess vessel patency and aorta stability. Delivery catheter is removed and discarded. The entire procedure is approximately one hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Procedure and Device-Related Adverse Events | Absence of major events (procedure and device-related) within the 1-month follow-up visit | Up to 30 days |
| Efficacy: Successful delivery of the EAST System into the AAA sac | Successful insertion of the delivery catheter and delivery of the Stabilizer Compound | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Evaluation of the AAA sac diameter over the 36 month follow up period. | Freedom from aneurysmal sac enlargement. Enlargement is defined as diameter increase of >5mm per year, or aneurysm sac volume increase of >10% per year, as assessed by CT scans at the 1, 3, (HK only), 6, 12, 24 and 36-month follow-up visits. | Through study completion, an average of 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Cheng, MD | Queen Mary Hospital, Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Private Hospital | Randwick | New South Wales | 2031 | Australia | ||
| Queen Mary Hospital |
| 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. 2023 Jun 15:S0741-5214(23)01313-7 | View source |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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Population diagnosed with small to medium-sized (3.5-5.0cm) abdominal aortic aneurym.
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|
| Efficacy: Evaluation of the AAA sac shrinkage over the 36 month follow up period. | Aneurysm sac shrinkage, defined as diameter decrease of >5mm, or decrease in aneurysm sac volume of >10% as assessed by CT scans at the 1, 3 (HK only), 6, 12, 24 and 36-month follow-up visits. | Through study completion, an average of 3 years |
| Hong Kong |
| Southern District |
| China |
| Pablo Tabon Uribe Hospital | MedellĂn | Antioquia | Colombia |
| Pauls Stradins Clinical University Hospital | Riga | Latvia |
| Auckland City Hospital | Auckland | New Zealand |