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

February 14, 2024 updated by: Vesteck, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Recruiting
        • Prince of Wales Private Hospital
        • Contact:
        • Contact:
          • Nicole Holland
          • Phone Number: +61 020965004947
        • Sub-Investigator:
          • Shannon Thomas, MD
        • Sub-Investigator:
          • Andrew Lennox, MD
        • Sub-Investigator:
          • Nedal Katib, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Adverse Events related to the Suture-Tight Suture Delivery System
Time Frame: 30-days
Recording of all Serious Adverse Event (SAE) related to the Suture-Tight™ Suture Delivery System procedure or device
30-days
Analysis of the Suture-Tight endoanchor effectiveness
Time Frame: 30-days

  1. 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
  2. Absence of a Type 1a Endo Leak
  3. Absence of a stent graft migration
30-days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vesteck, Inc.

Collaborators

Prince of Wales Hospital, Sydney

Investigators

  • Principal Investigator: Ramon Varcoe, MD, Prince of Wales Private Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2023

Primary Completion (Estimated)

July 19, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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