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

NCT05812768 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-02-16

No results posted yet for this study

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.

Conditions

  • Aortic Aneurysm, Abdominal

Interventions

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.

Sponsors & Collaborators

  • Prince of Wales Hospital, Sydney

    collaborator OTHER_GOV

  • Vesteck, Inc.

    lead INDUSTRY

Principal Investigators

  • Ramon Varcoe, MD · Prince of Wales Private Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-12
Primary Completion
2024-07-19
Completion
2024-07-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05812768 on ClinicalTrials.gov