Suture-Tight™ First-in-Human Safety and Performance Study

Sponsor

Vesteck, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05812768

Collaborator

Prince of Wales Hospital, Sydney (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm, Abdominal	Device: Suture-Tight Suture Delivery System	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Subjects meeting all inclusion/exclusion criteria and scheduled for an EVAR procedure.Subjects meeting all inclusion/exclusion criteria and scheduled for an EVAR procedure.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Suture-Tight™ First-in-Human Safety and Performance Study (CLP-05)

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Suture-Tight Subjects meeting all inclusion and exclusion criteria will receive graft anchoring utilizing the Suture-Tight Suture Delivery System.	Device: 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.

Arm

Intervention/Treatment

Experimental: Suture-Tight

Subjects meeting all inclusion and exclusion criteria will receive graft anchoring utilizing the Suture-Tight Suture Delivery System.

Device: 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.

Outcome Measures

Primary Outcome Measures

Serious Adverse Events related to the Suture-Tight Suture Delivery System [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 [30-days]
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

Secondary Outcome Measures

All cause safety events recorded during the study [6-months]
All-cause SAEs recorded during the EVAR procedure through follow-up.
Clinical Performance of the Stent Graft following Suture-Tight implant [6-months]
Evaluation of Changes in Stent graft patency, migration or displacement in follow-up as measured by an abdominal CT scan
Clinical Performance of the Suture-Tight following implant [6-months]
Evaluation of the Suture-Tight™ Suture migration, displacement, or fracture as measured by an abdominal CT scan and KUB x-rays.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 ≥ 5.5 cm in diameter (men) or ≥ 5.0 cm in diameter (women) 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.

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