NCT04070365

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2022

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

3 years

First QC Date

August 23, 2019

Last Update Submit

May 26, 2022

Conditions

Peripheral Artery DiseaseArteriovenous Fistula StenosisArteriovenous Graft Stenosis

Outcome Measures

Primary Outcomes (1)

  • Anatomic Success

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

    At the completion of the index procedure

Secondary Outcomes (7)

  • Technical Success of the Device

    At the index procedure

  • Clinical Success

    6 Months

  • Procedural Success

    6 Months

  • Target Lesion Primary Patency

    6, 9 and 12 Months

  • Circuit Primary Patency

    6, 9, and Months

  • +2 more secondary outcomes

Study Arms (1)

FLEX Vessel Prep followed by angioplasty

Device: FLEX Vessel Prep System followed by angioplasty

Interventions

FLEX Vessel Prep System followed by angioplastyDEVICE

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

Also known as: Balloon Angioplasty
FLEX Vessel Prep followed by angioplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

Flowers Hospital

Dothan, Alabama, 36305, United States

Location

University of Alabama

Tuscaloosa, Alabama, 35487, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

SSM Health SLU

St Louis, Missouri, 63117, United States

Location

FirstHealth Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

JOBST Vascular Institute

Toledo, Ohio, 43606, United States

Location

Dialysis Access Institute

Orangeburg, South Carolina, 29118, United States

Location

Richmond Vascular

Richmond, Virginia, 23235, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

AngioplastyCatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • John Aruny, MD

    Dialysis Access Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

May 28, 2018

Primary Completion

June 9, 2021

Study Completion

May 26, 2022

Last Updated

May 31, 2022

Record last verified: 2022-05

Locations

US(10)