{"id":3075256,"date":"2024-01-19T06:14:37","date_gmt":"2024-01-19T11:14:37","guid":{"rendered":"https:\/\/wordpress-1016567-4521551.cloudwaysapps.com\/plato-data\/nectero-starts-clinical-trial-for-endovascular-aneurysm-stabilisation-system\/"},"modified":"2024-01-19T06:14:37","modified_gmt":"2024-01-19T11:14:37","slug":"nectero-starts-clinical-trial-for-endovascular-aneurysm-stabilisation-system","status":"publish","type":"station","link":"https:\/\/platodata.io\/plato-data\/nectero-starts-clinical-trial-for-endovascular-aneurysm-stabilisation-system\/","title":{"rendered":"Nectero starts clinical trial for endovascular aneurysm stabilisation system"},"content":{"rendered":"

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Nectero EAST device received a fast-track designation from the US Food and Drug Administration (FDA) in August 2023. Image Credit: Suttha Burawonk \/ Shutterstock.<\/figcaption><\/figure>\n<\/p><\/div>\n

Arizona-based Nectro Medical has initiated a Phase II\/III trial evaluating the safety and efficacy of its endovascular aneurysm stabilisation treatment (Nectero EAST).<\/p>\n

Nectero EAST is a single-use, endovascular system made up of a dual-balloon delivery catheter and stabiliser mixture of pentagalloyl glucose (PGG). The PGG, when administered locally, can bind to elastin and collagen to potentially strengthen the aortic wall. Animal studies have shown that PGG can hinder the development of abdominal aortic aneurysm (AAA).<\/p>\n

TheT device received a fast-track designation from the US Food and Drug Administration<\/a> (FDA) in August 2023 and theprocedure can be completed in an hour without the need for any specialised tools.<\/p>\n

Nectero EAST clinical trial<\/h2>\n

The Phase II\/III stAAAble trial (NCT06001918) will investigate the safety and efficacy of the Nectero EAST device in patients with infrarenal AAAs, with a maximum diameter of 3.5\u20135 cm. The trial is expected to enrol 400 patients across multiple sites in the US andwill compare Nectero EAST  with the current standard of care \u2013 surveillance.<\/p>\n

The primary endpoint of the trial is the number of participants experiencing AAA-related death, rupture, and repair during the 24 months. The trial\u2019s secondary endpoint is growth in aneurysm diameter over time based on CT scan core laboratory readings at 24 months.<\/p>\n

Following the study\u2019s conclusion at 24 months, the patients will receive annual follow-ups till the fifth year since treatment.<\/p>\n

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