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

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
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    Eligibility

    Age eligible for study : 21 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-12-12

    Primary completion: 2024-07-19

    Study completion finish: 2024-07-31

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT05812768

    Intervention or treatment

    DEVICE: Suture-Tight Suture Delivery System

    Conditions

    • Aortic Aneurysm, Abdominal

    Find a site

    Closest Location:

    Prince of Wales Private Hospital

    Research sites nearby

    Select from list below to view details:

    • Prince of Wales Private Hospital

      Randwick, New South Wales, Australia

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    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?

    Participant Group/ArmIntervention/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

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Serious Adverse Events related to the Suture-Tight Suture Delivery SystemRecording of all Serious Adverse Event (SAE) related to the Suture-Tight™ Suture Delivery System procedure or device30-days
    Analysis of the Suture-Tight endoanchor effectiveness1. 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 migration30-days

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    All cause safety events recorded during the studyAll-cause SAEs recorded during the EVAR procedure through follow-up.6-months
    Clinical Performance of the Stent Graft following Suture-Tight implantEvaluation of Changes in Stent graft patency, migration or displacement in follow-up as measured by an abdominal CT scan6-months
    Clinical Performance of the Suture-Tight following implantEvaluation of the Suture-Tight™ Suture migration, displacement, or fracture as measured by an abdominal CT scan and KUB x-rays.6-months

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Suture-Tight™ First-in-Human Safety and Performance Study

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