FLEX®-DCB Dialysis ACCESS Stenosis Study

Arteriovenous Fistula Clinical Trial

— AVAFLEX  

Official title:

FLEX®-DCB Dialysis ACCESS Stenosis Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03566927
• Other study ID #: FLEX-DCB 0518-2
• Status: Terminated
• Phase: N/A
• Start date: May 29, 2018
• Est. completion date: December 10, 2019

Study information

• Verified date: February 2021
• Source: VentureMed Group Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: December 10, 2019
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula

Intervention

Combination Product:
• FLEX Scoring Catheter with Lutonix DCB
Treatment by the FLEX Scoring Catheter, a plain balloon angioplasty, followed by a Lutonix DCB.

Locations

Country	Name	City	State
United States	Dialysis Access Institute	Orangeburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VentureMed Group Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Index of Patency Function	Index of Patency Function defined as the average time between interventions.	3, 6, 9 Months
Secondary	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
Secondary	Number of Interventions	Mean cumulative interventions per subjects over study duration.	9 Months
Secondary	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