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Suture-Tight™ First-in-Human Safety and Performance Study
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 21 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-12-12
Primary completion: 2024-07-19
Study completion finish: 2024-07-31
Study type
TREATMENT
Phase
NA
Trial ID
NCT05812768
Intervention or treatment
DEVICE: Suture-Tight Suture Delivery System
Conditions
- • Aortic Aneurysm, Abdominal
Find a site
Closest Location:
Prince of Wales Private Hospital
Research sites nearby
Select from list below to view details:
Prince of Wales Private Hospital
Randwick, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Suture-Tight
| DEVICE: Suture-Tight Suture Delivery System
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| 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 | 30-days |
| Analysis of the Suture-Tight endoanchor effectiveness | 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 | 30-days |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| All cause safety events recorded during the study | All-cause SAEs recorded during the EVAR procedure through follow-up. | 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 | 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. | 6-months |
Frequently Asked Questions
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