FLEX®-DCB Dialysis ACCESS Stenosis Study

NCT ID: NCT03566927

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-29
• Study Completion Date: 2019-12-10

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.

Conditions

Arteriovenous Fistula

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

FLEX Scoring Catheter with Lutonix DCB

Intervention Type: COMBINATION_PRODUCT

Treatment by the FLEX Scoring Catheter, a plain balloon angioplasty, followed by a Lutonix DCB.

Interventions

FLEX Scoring Catheter with Lutonix DCB

Treatment by the FLEX Scoring Catheter, a plain balloon angioplasty, followed by a Lutonix DCB.

Intervention Type: COMBINATION_PRODUCT

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VentureMed Group Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dialysis Access Institute

Orangeburg, South Carolina, United States

Countries

United States

Other Identifiers

FLEX-DCB 0518-2

Identifier Type: -

Identifier Source: org_study_id