NCT05812768

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Vesteck, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-12
• Primary completion: 2024-07-19
• Completion: 2024-07-31
• First posted: 2023-04-14
• Last updated: 2024-02-16

Locations

1 site across 1 country: Australia