FLEX Arteriovenous Access Registry

N/ACompletedNCT04070365

VentureMed Group Inc.114 enrolled

Overview

Evaluation of the FLEX Vessel Prep system combined with angioplasty in the treatment of arteriovenous access stenosis.

Study Type

OBSERVATIONAL

Enrollment

114

Conditions

Peripheral Artery Disease Arteriovenous Fistula Stenosis Arteriovenous Graft Stenosis

Interventions

FLEX Vessel Prep System followed by angioplastyDEVICE

Eligible Arteriovenous Fistula (AVF)/Arteriovenous Graft (AVG) will be treated with the FLEX Vessel Prep system followed by angioplasty.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Hemodialysis patient currently scheduled to undergo an intervention of their arteriovenous fistula or graft due to clinical or hemodynamic abnormalities. 2. The patient is ≥18 years of age. Patient is legally competent, has been informed of the study, voluntarily agrees to participate, and has signed the inform consent form. 3. The patient has a reasonable expectation of remaining on hemodialysis for 12 months. 4. The patient understands the study and is willing and able to comply with follow-up requirements. 5. The patient is willing to provide informed consent. Exclusion Criteria: 1. The patient has a known or suspected systemic infection. 2. The patient has a known or suspected infection of the hemodialysis graft. 3. The patient has an untreatable allergy to radiographic contrast material. 4. In the opinion of the operating physician, the patient's hemodialysis access is unsuitable for endovascular treatment.

Locations (10)

Grandview Medical Center

Birmingham, Alabama, United States

Flowers Hospital

Dothan, Alabama, United States

University of Alabama

Tuscaloosa, Alabama, United States

Outcomes

Primary Outcomes

Anatomic Success

Defined as the angiographic percentage of stenosis post procedure as \<30%

Time frame: At the completion of the index procedure

Secondary Outcomes

Technical Success of the Device

Delivery to the target lesion, deployment of the treatment element, and retrieval

Time frame: At the index procedure

Clinical Success

The resumption of normal dialysis for at least one session.

Time frame: 6 Months

Procedural Success

Composite of anatomic and clinical success

Time frame: 6 Months

Target Lesion Primary Patency

The time interval of uninterrupted patency from initial study treatment to the next thrombosis or intervention performed on the target lesion

Time frame: 6, 9 and 12 Months

Circuit Primary Patency

The time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit.

Time frame: 6, 9, and Months

Assisted Primary Patency

The time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.

Time frame: 6, 9, and 12 Months

Access Secondary Patency

The time interval from initial study treatment to abandonment of the vascular access circuit.

Data from ClinicalTrials.gov

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