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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
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.
Prince of Wales Private Hospital
Randwick, New South Wales, Australia
RECRUITINGSerious 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
Time frame: 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
Time frame: 30-days
All cause safety events recorded during the study
All-cause SAEs recorded during the EVAR procedure through follow-up.
Time frame: 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
Time frame: 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.
Time frame: 6-months
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