FLEX®-DCB Dialysis ACCESS Stenosis Study

NCT03566927 | Terminated FDA Device

• 1 other identifier: FLEX-DCB 0518-2
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Index of Patency Function

  3, 6, 9 Months

• Assess Secondary Patency

  3, 6, 9 Months

• Number of Interventions

  9 Months

• Percentage of Patients with Freedom from Adverse Events

  1 Month

Study Arms (1)

FLEX Scoring Catheter plus DCB

EXPERIMENTAL

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

Interventions

FLEX Scoring Catheter with Lutonix DCB COMBINATION_PRODUCT

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

FLEX Scoring Catheter plus DCB

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VentureMed Group Inc.: lead

Study Sites (1)

Dialysis Access Institute

Orangeburg, South Carolina, 29118, United States

Location

MeSH Terms

Conditions

Arteriovenous Fistula; Vascular Fistula; Fistula; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 25, 2018
• Study Start: May 29, 2018
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

US (1)