Arteriovenous Fistula
Conditions
Keywords
Arteriovenous Fistula, Vascular Fistula, Scoring, Fistula, Cardiovascular Disease
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.
Interventions
COMBINATION_PRODUCTFLEX Scoring Catheter with Lutonix DCB
Treatment by the FLEX Scoring Catheter, a plain balloon angioplasty, followed by a Lutonix DCB.
Sponsors
VentureMed Group Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Index of Patency Function | 3, 6, 9 Months | Index of Patency Function defined as the average time between interventions. |
| 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. |
| Number of Interventions | 9 Months | Mean cumulative interventions per subjects over study duration. |
| 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. |
Countries
United States
Outcome results
None listed