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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05133492
Recruitment Status : Recruiting
First Posted : November 24, 2021
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Nectero Medical, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm AAA Dilation Aorta Device: Endovascular Aneurysm Stabilization Treatment (EAST) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Population diagnosed with small to medium-sized (3.5-5.0cm) abdominal aortic aneurym.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Pilot Study to Evaluate the Safety and Clinical Utility of The Nectero EAST System for Stabilization of Abdominal Aortic Aneurysms
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Interventional
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.
 Device: Endovascular Aneurysm Stabilization Treatment (EAST)
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. This takes approximately three minutes. 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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety: Procedure and Device-Related Adverse Events [ Time Frame: Up to 30 days ]
    Absence of major events (procedure and device-related) within the 1-month follow-up visit

  2. Efficacy: Successful delivery of the EAST System into the AAA sac [ Time Frame: Up to 30 days ]
    Successful insertion of the delivery catheter and delivery of the Stabilizer Compound


Secondary Outcome Measures :
  1. Efficacy: Evaluation of the AAA sac diameter over the 36 month follow up period. [ Time Frame: Through study completion, an average of 3 years ]
    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.

  2. Efficacy: Evaluation of the AAA sac shrinkage over the 36 month follow up period. [ Time Frame: Through study completion, an average of 3 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05133492


Contacts
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Contact: Rita Jacob (866) 755-4744 rjacob@necteromedical.com
Contact: Kelvin Ning (866) 755-4744 kning@necteromedical.com

Locations
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China, Southern District
Queen Mary Hospital Recruiting
Hong Kong, Southern District, China
Contact: Stephen Cheng, MD    +852 2255 2547    ctcentre@hku.hk   
Colombia
Pablo Tabon Uribe Hospital Recruiting
Medellín, Antioquia, Colombia
Contact: Santiago Echeverri, MD    +57+(604) 445 90 00      
New Zealand
Auckland City Hospital Not yet recruiting
Auckland, New Zealand
Contact: Andrew Holden, MD       AndrewH@adhb.govt.nz   
Contact: Elleni Takele       ElleniT@adhb.govt.nz   
Sponsors and Collaborators
Nectero Medical, Inc.
Investigators
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Principal Investigator: Stephen Cheng, MD Queen Mary Hospital, Hong Kong
More Information
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Additional Information:

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Responsible Party: Nectero Medical, Inc.
ClinicalTrials.gov Identifier: NCT05133492    
Other Study ID Numbers: CTP001
First Posted: November 24, 2021    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nectero Medical, Inc.:
Abdominal Aorta
Aneurysm
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases