FLEX Arteriovenous Access Registry

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

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease; Arteriovenous Fistula Stenosis; Arteriovenous Graft Stenosis
• Intervention / Treatment: Device: FLEX Vessel Prep System followed by angioplasty

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Center
    • Dothan, Alabama, United States, 36305
      • Flowers Hospital
    • Tuscaloosa, Alabama, United States, 35487
      • University of Alabama
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • SSM Health SLU
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • FirstHealth Moore Regional Hospital
  • Ohio
    • Toledo, Ohio, United States, 43606
      • Jobst Vascular Institute
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Dialysis Access Institute
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Richmond Vascular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Arteriovenous Fistula or Arteriovenous Graft Stenosis, eligible for FLEX/Angioplasty treatment.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Balloon Angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomic Success	Defined as the angiographic percentage of stenosis post procedure as <30%	At the completion of the index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success of the Device	Delivery to the target lesion, deployment of the treatment element, and retrieval	At the index procedure
Clinical Success	The resumption of normal dialysis for at least one session.	6 Months
Procedural Success	Composite of anatomic and clinical success	6 Months
Target Lesion Primary Patency	The time interval of uninterrupted patency from initial study treatment to the next thrombosis or intervention performed on the target lesion	6, 9 and 12 Months
Circuit Primary Patency	The time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit.	6, 9, and Months
Assisted Primary Patency	The time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.	6, 9, and 12 Months
Access Secondary Patency	The time interval from initial study treatment to abandonment of the vascular access circuit.	6, 9, and 12 Months

Collaborators and Investigators

• Sponsor: VentureMed Group Inc.
• Investigators: Principal Investigator: John Aruny, MD, Dialysis Access Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2018
• Primary Completion (Actual): June 9, 2021
• Study Completion (Actual): May 26, 2022

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Congenital Abnormalities; Atherosclerosis; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Peripheral Vascular Diseases; Arteriovenous Malformations; Vascular Fistula; Peripheral Arterial Disease; Fistula; Constriction, Pathologic; Arteriovenous Fistula
• Other Study ID Numbers: AV2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes