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: * Safety: absence of major events within the 1-month follow-up visit * Success: defined as successful insertion of the delivery catheter and delivery of the Stabilizer Secondary Study Endpoints: * 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. * 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. * Assessment of Clinical Utility Study duration is anticipated to be 6 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
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.
Prince of Wales Private Hospital
Randwick, New South Wales, Australia
Queen Mary Hospital
Hong Kong, Southern District, China
Pablo Tabon Uribe Hospital
Medellín, Antioquia, Colombia
Pauls Stradins Clinical University Hospital
Riga, Latvia
Safety: Procedure and Device-Related Adverse Events
Absence of major events (procedure and device-related) within the 1-month follow-up visit
Time frame: 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
Time frame: Up to 30 days
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.
Time frame: Through study completion, an average of 3 years
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.
Time frame: Through study completion, an average of 3 years
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Auckland City Hospital
Auckland, New Zealand