Clinical trial NCT05133492: First In Human Study for Small to Medium-sized Abdominal Aortic Aneurysm (AAA)
Official title: A Clinical Pilot Study to Evaluate the Safety and Clinical Utility of The Nectero EAST System for Stabilization of Abdominal Aortic Aneurysms
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Abdominal Aortic Aneurysm
AAA
Dilation Aorta
Keywords: Abdominal Aorta
Aneurysm
Lead sponsor: Nectero Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-24
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Population diagnosed with small to medium-sized (3.5-5.0cm) abdominal aortic aneurym.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Safety: Procedure and Device-Related Adverse Events
timeFrame: Up to 30 days
measure: Efficacy: Successful delivery of the EAST System into the AAA sac
timeFrame: Up to 30 days
Secondary outcomes:
measure: Efficacy: Evaluation of the AAA sac diameter over the 36 month follow up period.
timeFrame: Through study completion, an average of 3 years
measure: Efficacy: Evaluation of the AAA sac shrinkage over the 36 month follow up period.
timeFrame: Through study completion, an average of 3 years
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Prince of Wales Private Hospital
state: New South Wales
city: Hong Kong
country: China
facility: Queen Mary Hospital
state: Southern District
city: Medellín
country: Colombia
facility: Pablo Tabon Uribe Hospital
state: Antioquia
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: Queen Mary Hospital, Hong Kong
name: Stephen Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.