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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
Date last updated
16/02/2024

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
Single center, open label, prospective, single-arm, first-in-human (FIH), pre-market clinical study with the objective of validating the safety and performance of the Suture-Tight™ Suture Delivery System in an EVAR procedure.
Trial website
https://clinicaltrials.gov/study/NCT05812768
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05812768