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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05133492




Registration number
NCT05133492
Ethics application status
Date submitted
3/11/2021
Date registered
24/11/2021

Titles & IDs
Public title
First In Human Study for Small to Medium-sized Abdominal Aortic Aneurysm (AAA)
Scientific title
A Clinical Pilot Study to Evaluate the Safety and Clinical Utility of The Nectero EAST System for Stabilization of Abdominal Aortic Aneurysms
Secondary ID [1] 0 0
CTP001
Universal Trial Number (UTN)
Trial acronym
AAA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Aortic Aneurysm 0 0
AAA 0 0
Dilation Aorta 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Endovascular Aneurysm Stabilization Treatment (EAST)

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 Infusion Solution.


Treatment: Devices: 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. 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety: Procedure and Device-Related Adverse Events
Timepoint [1] 0 0
Up to 30 days
Primary outcome [2] 0 0
Efficacy: Successful delivery of the EAST System into the AAA sac
Timepoint [2] 0 0
Up to 30 days
Secondary outcome [1] 0 0
Efficacy: Evaluation of the AAA sac diameter over the 36 month follow up period.
Timepoint [1] 0 0
Through study completion, an average of 3 years
Secondary outcome [2] 0 0
Efficacy: Evaluation of the AAA sac shrinkage over the 36 month follow up period.
Timepoint [2] 0 0
Through study completion, an average of 3 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Prince of Wales Private Hospital - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Southern District
Country [2] 0 0
Colombia
State/province [2] 0 0
Antioquia
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Nectero Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Cheng, MD
Address 0 0
Queen Mary Hospital, Hong Kong
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05133492