Aortic Aneurysm, AbdominalSuture-Tight™NCT05812768
Suture-Tight™ First-in-Human Safety and Performance Study
A study testing Suture-Tight Suture Delivery System in people with Aortic Aneurysm, Abdominal, run by Vesteck, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- Suture-Tight Suture Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteAustralia
- Study dates
- 12 Dec 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Prince of Wales Private Hospital
Randwick, New South Wales, 2031
Kimberly Bassett, +61 020965004947, pow.vascular.institute@gmail.com
Nicole Holland, +61 020965004947
About this study
Official title: Suture-Tight™ First-in-Human Safety and Performance Study (CLP-05)
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.
Read the detailed description
Single center, study conducted at the Prince of Wales Private Hospital in Randwick, Australia. Up to 6 subjects may be enrolled. 1 to 3 subjects will complete initial enrollment and be followed for 30-days evaluating procedure and device safety. Additional subjects may be enrolled following the safety review to complete the 6-subject study. All subjects will be followed for six (6) months.
Subjects meeting all inclusion and exclusion criteria will be consented to receive an elective endovascular aortic aneurysm repair (EVAR) with graft anchoring utilizing the Suture-Tight device. Procedure and device safety and performance will be evaluated at 1- and 6-months by completing CT scans and KUB x-rays.
Data may be used to support a pivotal study of the investigational device and future global regulatory submissions.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- Suture-Tight Suture Delivery System
- Keywords
- EVAR, AAA, Anchor
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture-Tight Suture Delivery SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Suture-Tight | Experimental | Subjects meeting all inclusion and exclusion criteria will receive graft anchoring utilizing the Suture-Tight Suture Delivery System. Receives: Device: Suture-Tight Suture Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events related to the Suture-Tight Suture Delivery System
Recording of all Serious Adverse Event (SAE) related to the Suture-Tight™ Suture Delivery System procedure or device
Measured: 30-days
Analysis of the Suture-Tight endoanchor effectiveness
- 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
Measured: 30-days
Secondary outcomes (3)
All cause safety events recorded during the study
All-cause SAEs recorded during the EVAR procedure through follow-up.
Measured: 6-months
Clinical Performance of the Stent Graft following Suture-Tight implant
Evaluation of Changes in Stent graft patency, migration or displacement in follow-up as measured by an abdominal CT scan
Measured: 6-months
Clinical Performance of the Suture-Tight following implant
Evaluation of the Suture-Tight™ Suture migration, displacement, or fracture as measured by an abdominal CT scan and KUB x-rays.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start12 Dec 2023
- Primary completion19 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects meeting all inclusion/exclusion criteria and scheduled for an EVAR procedure.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vesteck, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Prince of Wales Hospital, Sydney
- Responsible party
- Sponsor
- Investigators
- Ramon Varcoe, MD, Principal investigator, Prince of Wales Private Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812768
- Sponsor's protocol ID
- CLP-05
- Acronym
- Suture-Tight™
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suture-Tight™ First-in-Human Safety and Performance Study (CLP-05)
- ClinicalTrials.gov ID
- NCT05812768
- Acronym / sponsor ID
- Suture-Tight™ / CLP-05
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- EVAR, AAA, Anchor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Vesteck, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Prince of Wales Hospital, Sydney
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 19 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Single center, study conducted at the Prince of Wales Private Hospital in Randwick, Australia. Up to 6 subjects may be enrolled. 1 to 3 subjects will complete initial enrollment and be followed for 30-days evaluating procedure and device safety. Additional subjects may be enrolled following the safety review to complete the 6-subject study. All subjects will be followed for six (6) months.
Subjects meeting all inclusion and exclusion criteria will be consented to receive an elective endovascular aortic aneurysm repair (EVAR) with graft anchoring utilizing the Suture-Tight device. Procedure and device safety and performance will be evaluated at 1- and 6-months by completing CT scans and KUB x-rays.
Data may be used to support a pivotal study of the investigational device and future global regulatory submissions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects meeting all inclusion/exclusion criteria and scheduled for an EVAR procedure.
| Arm | Type | Receives |
|---|---|---|
| Suture-Tight | Experimental | Device: Suture-Tight Suture Delivery SystemSubjects meeting all inclusion and exclusion criteria will receive graft anchoring utilizing the Suture-Tight Suture Delivery System. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suture-Tight Suture Delivery SystemImplantation 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. | Device | Suture-Tight |
Primary outcome
Serious Adverse Events related to the Suture-Tight Suture Delivery System
Time frame: 30-days
Recording of all Serious Adverse Event (SAE) related to the Suture-Tight™ Suture Delivery System procedure or device
Analysis of the Suture-Tight endoanchor effectiveness
Time frame: 30-days
1. 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 2. Absence of a Type 1a Endo Leak 3. Absence of a stent graft migration
3 secondary outcomes
All cause safety events recorded during the study
Time frame: 6-months
Clinical Performance of the Stent Graft following Suture-Tight implant
Time frame: 6-months
Clinical Performance of the Suture-Tight following implant
Time frame: 6-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramon Varcoe, MD principal investigator
Prince of Wales Private Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture-Tight Suture Delivery System in people with Aortic Aneurysm, Abdominal, run by Vesteck, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jerald L. Cox, PA (+1 760 529-6310, j.cox@vesteck.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events related to the Suture-Tight Suture Delivery System (time frame: 30-days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.