First In Human Study for Small to Medium-sized Abdominal Aortic Aneurysm (AAA)

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Clinical Pilot Study to Evaluate the Safety and Clinical Utility of The Nectero EAST System for Stabilization of Abdominal Aortic Aneurysms

Conditions
-----------------
AAA, Dilation Aorta, Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Device: Endovascular Aneurysm Stabilization Treatment (EAST)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female aged 18 years or older Subject can understand the purpose of the trial, voluntarily participate in the trial and sign the informed consent and is willing to complete the follow-up according to the requirements of the protocol. Infrarenal non-aneurysmal neck ≥15mm in length Aortic neck diameters ≤ 29mm Infrarenal neck angulation ≤ 60° Abdominal aneurysm from 3.5 cm to 5.0 cm. Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 10 cm Patient iliac or femoral arteries access vessels' size and morphology allow endovascular access of 14F introducer sheaths and catheters. Subject has > one-year life expectancy. Subject is American Society of Anesthesiology (ASA) grade 1 through 3, inclusive. Subject is able and willing to comply with 1, 3, 6, 12, 24 and 36-month follow-up. Exclusion Criteria: Subject has an acutely ruptured or leaking or emergent aneurysm. Subject has a dissecting aneurysm. Subject has a mycotic or infected aneurysm. Subject has current vascular injury due to trauma. Subject's aneurysm is thoracic or suprarenal. Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm. Subject has thrombus, calcification, and/or plaque that may compromise delivery. Subject has had a myocardial infarction within six (6) months prior to enrollment. Subject has current angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia, or valvular disease. Subject has undergone other major surgery within the 30 days prior to enrollment. Subjects with any transient ischemic attack (TIA) or ischemic stroke within 3 months. Known allergy to polyester or contrast material that cannot be pretreated. Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta. Subject has connective tissue disease (e.g., Marfan syndrome, Eaton syndrome, or Bessel's disease). Known contraindication to undergoing angiography or anticoagulation. Subject has active systemic infection. Subject is participating in another research study. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment. Women of childbearing potential who are pregnant, lactating, or planning to become pregnant during the course of the trial. Subject has dialysis dependent renal failure or baseline serum creatinine level >2.0mg/dl. Subjects with liver dysfunction: alanine transaminase (ALT) or aspartate transaminase (AST) is five times higher than the normal upper limit; serum total bilirubin (STB) is two times higher than the normal upper limit. Subjects who are not suitable for endovascular treatment, as judged by the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Population diagnosed with small to medium-sized (3.5-5.0cm) abdominal aortic aneurym.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>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. | Device: Endovascular Aneurysm Stabilization Treatment (EAST)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal Aorta, Aneurysm