stAAAble: Nectero EAST System Clinical Study

Sponsor

Nectero Medical, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06001918

Collaborator

(none)

400

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm	Drug: Nectero EAST System	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, randomized, controlled trial comparing the efficacy of the treatment arm to the control arm.Prospective, randomized, controlled trial comparing the efficacy of the treatment arm to the control arm.

Masking:

Single (Outcomes Assessor)

Masking Description:

For this trial, neither the patient nor investigator will be blinded to the study group assignment. However, members of the Sponsor, the CT core laboratory and the various committees reviewing subject data, such as the Clinical Events Committee (CEC), will be blinded to the randomization and assignment arm for an individual subject under review.

Primary Purpose:

Treatment

Official Title:

Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy.

Anticipated Study Start Date :

Oct 31, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Arm Participants assigned to the treatment arm 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. Following treatment, surveillance of their AAA will be conducted using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years. Intervention: Drug: Stabilizer	Drug: Nectero EAST System Treated subjects will undergo an endovascular procedure with the Nectero EAST system and receive the Stabilizer Infusion Solution (drug) within 30 days of the study eligibility by CT scan as a one-time local delivery of the drug.
No Intervention: Control Arm Participants assigned to the control arm will undergo surveillance of their AAA using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years.

Arm

Intervention/Treatment

Experimental: Treatment Arm

Participants assigned to the treatment arm 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. Following treatment, surveillance of their AAA will be conducted using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years. Intervention: Drug: Stabilizer

Drug: Nectero EAST System

Treated subjects will undergo an endovascular procedure with the Nectero EAST system and receive the Stabilizer Infusion Solution (drug) within 30 days of the study eligibility by CT scan as a one-time local delivery of the drug.

No Intervention: Control Arm

Participants assigned to the control arm will undergo surveillance of their AAA using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years.

Outcome Measures

Primary Outcome Measures

Primary Endpoint [24 months]
The primary endpoint is the number of participants experiencing AAA-related death, rupture and repair (open-surgical, EVAR, or clinically indicated for repair as adjudicated by a committee of clinical experts blinded to the assigned arm).

Secondary Outcome Measures

Growth [24 months]
The growth over time in aneurysm diameter based on CT core laboratory readings.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Males and females ≥21 years of age. Females must be of non-childbearing potential (menopause or sterilization).
Subject understands the purpose of the trial, agrees to voluntarily participate in the trial, signs the informed consent and is willing to complete the follow-up according to the requirements of the protocol.
Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female).
Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 130 mm.
Iliac and femoral artery access, vessel size and morphology allow endovascular access of 14F (or larger) introducer sheaths and catheters, including severe infrarenal neck angulation.
Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria, inclusive.
Subject has > two-year life expectancy.
Subject is able and willing to comply with all required follow-up clinic visits including CT scans (pre-randomization, 6, 12, 18, 24 months and annually up to 5 years).

Exclusion Criteria:

Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm.
Subject has a symptomatic infrarenal abdominal aortic aneurysm.
Subject has a mycotic or infected aneurysm.
Subject has current vascular injury due to trauma.
Subject's aneurysm is thoracic, suprarenal or juxtarenal.
Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
Subject has anatomy of diffuse, ulcerated, or extensive (shaggy) thrombus in the neck of the AAA, that in the opinion of the vascular surgeon/investigator, could result in embolization of the thrombus.
Subject has anatomy of calcification, and/or plaque within the ilio-femoral arteries that may compromise or does not allow delivery of the Introducer Sheath or the delivery catheter of the Nectero EAST System.
Subject has had a myocardial infarction within six (6) months prior to enrollment or elevated CK enzymes or troponin prior to procedure.
Subject has current angina, unstable angina, or other active cardiac condition such as congestive heart failure III and IV, 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 contrast material, delivery system materials (i.e., nylon, polyurethane) and/or Pentagalloyl Glucose (PGG).
Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
Subject has connective tissue/collagen disorder (e.g., Marfan syndrome, vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, Eaton Syndrome, Bessel-Hagen disease, etc.).
Known contraindication to undergoing angiography or receiving systemic anticoagulation.
Subject has active systemic infection.
Subject is participating in another research trial that could interfere with the results of the trial (e.g., drug trial).
Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from participation in the trial and to undergo the procedures and evaluations pre- and post-treatment.
Subject has dialysis dependent renal failure or baseline serum creatinine level

2.5mg/dL or eGFR < 45 mL/min/1.73m2.

Subjects with liver dysfunction: alanine transaminase (ALT) or aspartate transaminase (AST) which is 3 times higher than the normal upper limit; serum total bilirubin (STB) that is 1.5 times higher than the normal upper limit or has clinical evidence of jaundice.
Subjects that may not tolerate the lowering of their systolic blood pressure to approximately 100mmHg, should not be considered for this study or treated using the Nectero EAST System.
Subjects that may not be able to tolerate transient occlusion of the aorta should not be considered for this study.
Subjects with saccular AAA.
Subjects with rapidly expanding AAA (previous diameter increases of ≥0.5 cm in 6-months or ≥1 cm in 1 year) as these should be evaluated for immediate repair.
Subjects who are not suitable for the Nectero EAST System treatment, as determined by the investigator.