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Trial record 2 of 5 for:    FLEX | Arteriovenous Fistula

FLEX Arteriovenous Access Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04070365
Recruitment Status : Recruiting
First Posted : August 27, 2019
Last Update Posted : October 14, 2019
Information provided by (Responsible Party):
VentureMed Group Inc.

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

Condition or disease Intervention/treatment
Peripheral Artery Disease Arteriovenous Fistula Stenosis Arteriovenous Graft Stenosis Device: FLEX Vessel Prep System followed by angioplasty

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: FLEX Arteriovenous Access Registry
Actual Study Start Date : October 9, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Group/Cohort Intervention/treatment
FLEX Vessel Prep followed by angioplasty Device: FLEX Vessel Prep System followed by angioplasty
Eligible Arteriovenous Fistula (AVF)/Arteriovenous Graft (AVG) will be treated with the FLEX Vessel Prep system followed by angioplasty.
Other Name: Balloon Angioplasty

Primary Outcome Measures :
  1. Anatomic Success [ Time Frame: At the completion of the index procedure ]
    Defined as the angiographic percentage of stenosis post procedure as <30%

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Arteriovenous Fistula or Arteriovenous Graft Stenosis, eligible for FLEX/Angioplasty treatment.

Inclusion Criteria:

  1. Hemodialysis patient currently scheduled to undergo an intervention of their arteriovenous fistula or graft due to clinical or hemodynamic abnormalities.
  2. 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.
  3. The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
  4. The patient understands the study and is willing and able to comply with follow-up requirements.
  5. The patient is willing to provide informed consent.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04070365

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Contact: Katy Feeny 7632962027

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United States, North Carolina
FirstHealth Moore Regional Hospital Recruiting
Pinehurst, North Carolina, United States, 28374
United States, South Carolina
Dialysis Access Institute Not yet recruiting
Orangeburg, South Carolina, United States, 29118
Sponsors and Collaborators
VentureMed Group Inc.
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Principal Investigator: John Aruny, MD Dialysis Access Institute

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Responsible Party: VentureMed Group Inc. Identifier: NCT04070365     History of Changes
Other Study ID Numbers: AV2019
First Posted: August 27, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Arteriovenous Fistula
Arteriovenous Malformations
Vascular Fistula
Peripheral Arterial Disease
Constriction, Pathologic
Pathological Conditions, Anatomical
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities