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

Aortic Aneurysm, Abdominal Clinical Trial

— Suture-Tight™  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05812768
• Other study ID #: CLP-05
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2023
• Source: Vesteck, Inc.
• Contact: Jerald L. Cox, PA
• Phone: +1 760 529-6310
• Email: j.cox[@]vesteck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: July 31, 2024
• Est. primary completion date: July 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

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.

Locations

Country	Name	City	State
Australia	Prince of Wales Private Hospital	Randwick	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Vesteck, Inc.	Prince of Wales Hospital, Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	30-days
Secondary	All cause safety events recorded during the study	All-cause SAEs recorded during the EVAR procedure through follow-up.	6-months
Secondary	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
Secondary	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