FLEX®-DCB Dialysis ACCESS Stenosis Study (AVAFLEX)

• ClinicalTrials.gov Identifier: NCT03566927
• Recruitment Status: Active, not recruiting
• First Posted: June 25, 2018
• Last Update Posted: August 28, 2019
• Sponsor: VentureMed Group Inc.
• Information provided by (Responsible Party): VentureMed Group Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Arteriovenous Fistula	Combination Product: FLEX Scoring Catheter with Lutonix DCB	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: FLEX®-DCB Dialysis ACCESS Stenosis Study
• Actual Study Start Date: May 29, 2018
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: December 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Target Lesion Primary Patency [ Time Frame: 9 Months ]
   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.

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, South Carolina

Dialysis Access Institute

Orangeburg, South Carolina, United States, 29118

Sponsors and Collaborators

VentureMed Group Inc.

More Information

• Responsible Party: VentureMed Group Inc.
• ClinicalTrials.gov Identifier: NCT03566927
• Other Study ID Numbers: FLEX-DCB 0518-2
• First Posted: June 25, 2018
• Last Update Posted: August 28, 2019
• Last Verified: August 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by VentureMed Group Inc.:

Arteriovenous Fistula; Vascular Fistula; Scoring; Fistula; Cardiovascular Disease

Additional relevant MeSH terms:

Arteriovenous Fistula; Fistula; Pathological Conditions, Anatomical; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities