Brief Title
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
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. Thirty (30) 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
Primary Outcome
Safety: Procedure and Device-Related Adverse Events
Secondary Outcome
Efficacy: Evaluation of the AAA sac diameter over the 36 month follow up period.
Condition
Abdominal Aortic Aneurysm
Intervention
Endovascular Aneurysm Stabilization Treatment (EAST)
Study Arms / Comparison Groups
Interventional
Description: 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 Compound.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
30
Start Date
June 24, 2019
Completion Date
May 31, 2025
Primary Completion Date
May 31, 2022
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 ≤ 28mm
- 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Stephen Cheng, MD, (866) 755-4744, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT05133492
Organization ID
CTP001
Responsible Party
Sponsor
Study Sponsor
Nectero Medical, Inc.
Study Sponsor
Stephen Cheng, MD, Principal Investigator, Queen Mary Hospital, Hong Kong
Verification Date
November 2021