FLEX®-DCB Dialysis ACCESS Stenosis Study (AVAFLEX)

This prospective, single arm, single-center study is designed to evaluate the performance of the FLEX Scoring Catheter®/POBA/DCB in A-V access circuits.

Study Overview

• Status: Terminated
• Conditions: Arteriovenous Fistula
• Intervention / Treatment: Combination product: FLEX Scoring Catheter with Lutonix DCB

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Dialysis Access Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient is legally competent, has been informed of the study, voluntarily agrees to participate, and has signed the informed consent form.
• Arteriovenous fistula is located in the arm.
• Native AV fistula / graft was created ≥ 30 days prior to the initial procedure and has undergone at least one hemodialysis sessions.
• Venous stenosis of the AV fistula / graft with the target lesion located from the anastomosis to the axillosubclavian junction and an abnormality attributable to the stenosis as defined by K/DOQI guidelines.
• Patients with a dysfunctional or thrombosed hemodialysis access and a >50% stenosis, regardless of prior treatment (All types of lesion and access failure)
• If AV access is thrombosed, must undergo a successful thrombectomy with minimal residual thrombus.
• Intended target lesion or if a tandem lesion can be treated with ≤120 mm of DCBs in length.

Exclusion Criteria:

• Life expectancy < 9 months
• Women who are pregnant, lactating, or planning on becoming pregnant during the duration of the study.
• The hemodialysis access is located in the leg.
• Patient has more than two lesions in the access circuit.
• Patient has a secondary non-target lesion that cannot be successfully treated
• Target lesion is located central to the axillosubclavian junction.
• Surgical revision of the access site planned.
• Recent surgical interventions of the access site.
• Known allergy or sensitivity to iodinated contrast media, that cannot be adequately managed with pre- and post-procedure medication.
• Known allergy or sensitivity to paclitaxel.
• Patients who are taking immunosuppressive therapy, or routinely taking ≥ 10 mg of prednisone per day.
• Patients who have a medical condition, in the opinion of the Investigator, that may cause the patient to be noncompliant to the protocol or confound the data.
• Patients anticipating a kidney transplant.
• Patients anticipating a conversion to peritoneal dialysis.
• The patient has a stent located in the target or secondary non-target lesion.
• Patient has an active infection in the AV access or a systemic infection.
• Known hyper-coagulable state
• Currently participating in an investigational drug, biologic, or device study.
• Previously enrolled in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FLEX Scoring Catheter plus DCB; This is a single-arm study. All patients will be treated with the FLEX Scoring Catheter, then a standard balloon angioplasty, followed by a Lutonix® drug-coated balloon (DCB).	Combination product: FLEX Scoring Catheter with Lutonix DCB; Treatment by the FLEX Scoring Catheter, a plain balloon angioplasty, followed by a Lutonix DCB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Primary Patency	Target Lesion Primary Patency at 9 months defined as the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.	9 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Index of Patency Function	Index of Patency Function defined as the average time between interventions.	3, 6, 9 Months
Assess Secondary Patency	Assess Secondary Patency defined as the time interval from initial study treatment to abandonment of the vascular access circuit.	3, 6, 9 Months
Number of Interventions	Mean cumulative interventions per subjects over study duration.	9 Months
Percentage of Patients with Freedom from Adverse Events	Freedom from major device, procedure and treatment site-related adverse events through 30 days' post procedure.	1 Month

Collaborators and Investigators

• Sponsor: VentureMed Group Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2018
• Primary Completion (Actual): December 10, 2019
• Study Completion (Actual): December 10, 2019

Study Registration Dates

• First Submitted: June 12, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Cardiovascular Disease; Fistula; Arteriovenous Fistula; Vascular Fistula; Scoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: FLEX-DCB 0518-2

Drug and device information, study documents

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