FLEX®-DCB Dialysis ACCESS Stenosis Study

Not Applicable

Terminated

• Conditions: Arteriovenous Fistula
• Interventions: Combination Product: FLEX Scoring Catheter with Lutonix DCB

• Registration Number: NCT03566927
• Lead Sponsor: VentureMed Group Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-29
• Study First Submitted: 2018-06-12
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-25
• Primary Completion: 2019-12-10
• Study Completion: 2019-12-10
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FLEX Scoring Catheter plus DCB	FLEX Scoring Catheter with Lutonix 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).

Primary Outcome Measures

Name	Time	Method
Target Lesion Primary Patency	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

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

Trial Locations

Locations (1)

Dialysis Access Institute; 🇺🇸 Orangeburg, South Carolina, United States