Register a trial

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05812768




Registration number
NCT05812768
Ethics application status
Date submitted
27/03/2023
Date registered
14/04/2023

Titles & IDs
Public title
Suture-Tight™ First-in-Human Safety and Performance Study
Scientific title
Suture-Tight™ First-in-Human Safety and Performance Study (CLP-05)
Secondary ID [1] 0 0
CLP-05
Universal Trial Number (UTN)
Trial acronym
Suture-Tight™
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Aneurysm, Abdominal 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 - Suture-Tight Suture Delivery System

Experimental: Suture-Tight - Subjects meeting all inclusion and exclusion criteria will receive graft anchoring utilizing the Suture-Tight Suture Delivery System.


Treatment: Devices: Suture-Tight Suture Delivery System
Implantation of the Suture-Tight Suture in the deployment of multiple nitinol sutures to provide augmented fixation and sealing between endovascular aortic graft and the native artery.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Serious Adverse Events related to the Suture-Tight Suture Delivery System
Timepoint [1] 0 0
30-days
Primary outcome [2] 0 0
Analysis of the Suture-Tight endoanchor effectiveness
Timepoint [2] 0 0
30-days
Secondary outcome [1] 0 0
All cause safety events recorded during the study
Timepoint [1] 0 0
6-months
Secondary outcome [2] 0 0
Clinical Performance of the Stent Graft following Suture-Tight implant
Timepoint [2] 0 0
6-months
Secondary outcome [3] 0 0
Clinical Performance of the Suture-Tight following implant
Timepoint [3] 0 0
6-months

Eligibility
Key inclusion criteria
* Currently scheduled for an elective endovascular repair of an abdominal aortic aneurysm (AAA) by EVAR with CT scan from within last 4 months. Acceptable AAA parameters include: AAA = 5.0 cm in diameter OR AAA = 4.5 cm in diameter with an increase of = 0.5 cm within the past 6-months or = 1.0 cm over the past 12-months
* Neck diameter, length and angulation that meets labeling requirements for the endograft used
* Successful EVAR graft placement with no evidence of EVAR-associated serious adverse event.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Mycotic or inflammatory AAA
* Prior surgical repair of an AAA
* Renal dialysis or significant chronic renal failure
* Evidence of recent acute coronary disease, thrombotic disease, or cerebral infarct
* Pregnancy

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
6
Accrual to date
Final
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

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vesteck, Inc.
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Prince of Wales Hospital, Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Ramon Varcoe, MD
Address 0 0
Prince of Wales Private Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jerald L. Cox, PA
Address 0 0
Country 0 0
Phone 0 0
+1 760 529-6310
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT05812768