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FLEX®-DCB Dialysis ACCESS Stenosis Study (AVAFLEX)

Primary Purpose

Arteriovenous Fistula

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FLEX Scoring Catheter with Lutonix DCB

About this trial

This is an interventional treatment trial for Arteriovenous Fistula focused on measuring Arteriovenous Fistula, Vascular Fistula, Scoring, Fistula, Cardiovascular Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Dialysis Access Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FLEX Scoring Catheter plus DCB

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Index of Patency Function

Index of Patency Function defined as the average time between interventions.

Assess Secondary Patency

Assess Secondary Patency defined as the time interval from initial study treatment to abandonment of the vascular access circuit.

Number of Interventions

Mean cumulative interventions per subjects over study duration.

Percentage of Patients with Freedom from Adverse Events

Freedom from major device, procedure and treatment site-related adverse events through 30 days' post procedure.

Full Information

NCT ID

NCT03566927

First Posted

June 12, 2018

Last Updated

February 15, 2021

Sponsor

VentureMed Group Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03566927

Brief Title

FLEX®-DCB Dialysis ACCESS Stenosis Study

Acronym

AVAFLEX

Official Title

FLEX®-DCB Dialysis ACCESS Stenosis Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Terminated

Why Stopped

Terminated due to warning letters issued regarding paclitaxel

Study Start Date

May 29, 2018 (Actual)

Primary Completion Date

December 10, 2019 (Actual)

Study Completion Date

December 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VentureMed Group Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arteriovenous Fistula

Keywords

Arteriovenous Fistula, Vascular Fistula, Scoring, Fistula, Cardiovascular Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FLEX Scoring Catheter plus DCB

Arm Type

Experimental

Arm Description

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).

Intervention Type

Combination Product

Intervention Name(s)

FLEX Scoring Catheter with Lutonix DCB

Intervention Description

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

Primary Outcome Measure Information:

Title

Target Lesion Primary Patency

Description

Time Frame

9 Months

Secondary Outcome Measure Information:

Title

Index of Patency Function

Description

Index of Patency Function defined as the average time between interventions.

Time Frame

3, 6, 9 Months

Title

Assess Secondary Patency

Description

Assess Secondary Patency defined as the time interval from initial study treatment to abandonment of the vascular access circuit.

Time Frame

3, 6, 9 Months

Title

Number of Interventions

Description

Mean cumulative interventions per subjects over study duration.

Time Frame

9 Months

Title

Percentage of Patients with Freedom from Adverse Events

Description

Freedom from major device, procedure and treatment site-related adverse events through 30 days' post procedure.

Time Frame

1 Month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Dialysis Access Institute

City

Orangeburg

State/Province

South Carolina

ZIP/Postal Code

29118

Country

United States

12. IPD Sharing Statement

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FLEX®-DCB Dialysis ACCESS Stenosis Study

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