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

Aortic Aneurysm, Abdominal Clinical Trial

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

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05812768
Study type Interventional
Source Vesteck, Inc.
Contact Jerald L. Cox, PA
Phone +1 760 529-6310
Email j.cox@vesteck.com
Status Recruiting
Phase N/A
Start date December 12, 2023
Completion date July 31, 2024
View Details
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