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Completed

NCT Number: NCT04070365

FLEX Arteriovenous Access Registry

Evaluation of the FLEX Vessel Prep system combined with angioplasty in the treatment of arteriovenous access stenosis.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Arteriovenous Fistula Stenosis Arteriovenous Graft Stenosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Grandview Medical Center, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemodialysis patient currently scheduled to undergo an intervention of their arteriovenous fistula or graft due to clinical or hemodynamic abnormalities.
  • The patient is ≥18 years of age. Patient is legally competent, has been informed of the study, voluntarily agrees to participate, and has signed the inform consent form.
  • The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
  • The patient understands the study and is willing and able to comply with follow-up requirements.
  • The patient is willing to provide informed consent.

Exclusion criteria

  • The patient has a known or suspected systemic infection.
  • The patient has a known or suspected infection of the hemodialysis graft.
  • The patient has an untreatable allergy to radiographic contrast material.
  • In the opinion of the operating physician, the patient's hemodialysis access is unsuitable for endovascular treatment.

Treatment and study plan

FLEX Vessel Prep System followed by angioplasty

Device

Eligible Arteriovenous Fistula (AVF)/Arteriovenous Graft (AVG) will be treated with the FLEX Vessel Prep system followed by angioplasty.

Other names: Balloon Angioplasty

Primary outcomes

  1. Anatomic Success

    Time frame: At the completion of the index procedure

    Defined as the angiographic percentage of stenosis post procedure as <30%

Secondary outcomes

  1. Technical Success of the Device

    Time frame: At the index procedure

    Delivery to the target lesion, deployment of the treatment element, and retrieval

  2. Clinical Success

    Time frame: 6 Months

    The resumption of normal dialysis for at least one session.

  3. Procedural Success

    Time frame: 6 Months

    Composite of anatomic and clinical success

  4. Target Lesion Primary Patency

    Time frame: 6, 9 and 12 Months

    The time interval of uninterrupted patency from initial study treatment to the next thrombosis or intervention performed on the target lesion

  5. Circuit Primary Patency

    Time frame: 6, 9, and Months

    The time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit.

  6. Assisted Primary Patency

    Time frame: 6, 9, and 12 Months

    The time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.

  7. Access Secondary Patency

    Time frame: 6, 9, and 12 Months

    The time interval from initial study treatment to abandonment of the vascular access circuit.

Sponsors and collaborators

Lead sponsor

VentureMed Group Inc.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Aug 28, 2019
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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