Clinical trial NCT03566927: FLEX®-DCB Dialysis ACCESS Stenosis Study
Official title: FLEX®-DCB Dialysis ACCESS Stenosis Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arteriovenous Fistula
Keywords: Arteriovenous Fistula
Vascular Fistula
Scoring
Fistula
Cardiovascular Disease
Lead sponsor: VentureMed Group Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-25
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Target Lesion Primary Patency
timeFrame: 9 Months
Secondary outcomes:
measure: Index of Patency Function
timeFrame: 3, 6, 9 Months
measure: Assess Secondary Patency
timeFrame: 3, 6, 9 Months
measure: Number of Interventions
timeFrame: 9 Months
measure: Percentage of Patients with Freedom from Adverse Events
timeFrame: 1 Month
Other outcomes:
Locations:
city: Orangeburg
country: United States
facility: Dialysis Access Institute
state: South Carolina
Study officials:
References: