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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
Suture-Tight™ First-in-Human Safety and Performance Study (CLP-05)
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Secondary ID [1]
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CLP-05
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Universal Trial Number (UTN)
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Trial acronym
Suture-Tight™
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aortic Aneurysm, Abdominal
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Serious Adverse Events related to the Suture-Tight Suture Delivery System
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Assessment method [1]
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Recording of all Serious Adverse Event (SAE) related to the Suture-Tight™ Suture Delivery System procedure or device
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Timepoint [1]
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30-days
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Primary outcome [2]
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Analysis of the Suture-Tight endoanchor effectiveness
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Assessment method [2]
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Documentation of Procedural success defined as:
Successful delivery of the Suture-Tight™ Delivery Catheter to the site of intended treatment
Successful removal of Suture-Tight™ Delivery Catheter
Absence of evidence of acute endograft migration or dysfunction at the conclusion of the procedure
Absence of a Type 1a Endo Leak
Absence of a stent graft migration
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Timepoint [2]
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30-days
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Secondary outcome [1]
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All cause safety events recorded during the study
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Assessment method [1]
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All-cause SAEs recorded during the EVAR procedure through follow-up.
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Timepoint [1]
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6-months
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Secondary outcome [2]
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Clinical Performance of the Stent Graft following Suture-Tight implant
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Assessment method [2]
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Evaluation of Changes in Stent graft patency, migration or displacement in follow-up as measured by an abdominal CT scan
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Timepoint [2]
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6-months
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Secondary outcome [3]
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Clinical Performance of the Suture-Tight following implant
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Assessment method [3]
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Evaluation of the Suture-Tight™ Suture migration, displacement, or fracture as measured by an abdominal CT scan and KUB x-rays.
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Timepoint [3]
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6-months
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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.
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Minimum age
21
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/12/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/07/2024
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Actual
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Sample size
Target
6
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Prince of Wales Private Hospital - Randwick
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Recruitment postcode(s) [1]
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2031 - Randwick
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Vesteck, Inc.
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Prince of Wales Hospital, Sydney
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05812768
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ramon Varcoe, MD
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Address
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Prince of Wales Private Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jerald L. Cox, PA
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Address
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Country
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Phone
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+1 760 529-6310
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05812768
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