FLEX FIRST Registry Research Protocol

Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities following 12 months post treatment.

Study Overview

• Status: Recruiting
• Conditions: Arterial Occlusive Diseases; Fistula; Arteriovenous Fistula; Arteriovenous Graft
• Intervention / Treatment: Device: FLEX Vessel Prep System

Detailed Description

Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities in real-world subjects per the Institution's standard practice and at 1-, 6-, and 12-months following treatment.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Jill Schweiger; Phone Number: 763-296-2021; Email: jschweiger@venturemedgroup.com

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33169
      • Recruiting
      • Open Access Vascular Access
      • Contact: Olga Pazos
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Recruiting
      • Minneapolis Vascular Surgery Center
      • Contact: Colleen Guest
      • Principal Investigator: Scott R Schultz, MD
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Recruiting
      • Dialysis Access Institute
      • Principal Investigator: John Aruny, MD
      • Contact: Amy Lawson
      • Contact: Virginia Anderson
    • Spartanburg, South Carolina, United States, 29303
      • Recruiting
      • Spartanburg Regional Health
      • Contact: Darla Howard
      • Principal Investigator: Ari Kramer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects with AVF/AVG stenosis who are eligible for FLEX/Angioplasty treatment

Description

Inclusion Criteria:

1. Subject is ≥18 years of age.

2. Subject is currently scheduled to undergo an endovascular intervention of arteriovenous fistula or graft due to clinical and hemodynamic abnormalities meeting the KDOQI Guidelines for AV access dysfunction:

   • Elevated venous pressure during hemodialysis,
   • Abnormal physical findings, and
   • Unexplained decrease in delivered dialysis dose.
3. Subject has a reasonable expectation of remaining on hemodialysis for ≥12 months.
4. Subject is legally competent, informed of the study, voluntarily agrees to participate, and signs the informed consent form.
5. Subject understands the study and is willing and able to comply with the follow-up requirements.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

FLEX Vessel Prep followed by angioplasty; Eligible subjects will be treated with the FLEX Vessel Prep system followed by balloon angioplasty.

Device: FLEX Vessel Prep System; The FLEX Vessel Prep System to create circumferential, continuous micro-incisions along the length of the stenosis by performing a retrograde pullback through the lesion. Following FLEX, standard balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding Instructions for Use. Once advanced into the lesion, the balloon should be inflated according to the site's standard of care.; Other Names: Balloon Angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Primary Patency Rate	Defined as freedom from clinically driven target lesion re-intervention (CD-TLR) or access circuit thrombosis measured through 6-months post- procedure.	6 months post procedure
Serious Adverse Event Rate	Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 1-month post-procedure.	1 month

Collaborators and Investigators

• Sponsor: VentureMed Group Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arterial Occlusive Diseases; Arteriovenous Fistula
• Other Study ID Numbers: VMG-2022-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No