Clinical trial NCT04070365: FLEX Arteriovenous Access Registry
Official title: FLEX Arteriovenous Access Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Arteriovenous Fistula Stenosis
Arteriovenous Graft Stenosis
Lead sponsor: VentureMed Group Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Arteriovenous Fistula or Arteriovenous Graft Stenosis, eligible for FLEX/Angioplasty treatment.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Anatomic Success
timeFrame: At the completion of the index procedure
Secondary outcomes:
measure: Technical Success of the Device
timeFrame: At the index procedure
measure: Clinical Success
timeFrame: 6 Months
measure: Procedural Success
timeFrame: 6 Months
measure: Target Lesion Primary Patency
timeFrame: 6, 9 and 12 Months
measure: Circuit Primary Patency
timeFrame: 6, 9, and Months
measure: Assisted Primary Patency
timeFrame: 6, 9, and 12 Months
measure: Access Secondary Patency
timeFrame: 6, 9, and 12 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Dothan
country: United States
facility: Flowers Hospital
state: Alabama
city: Tuscaloosa
country: United States
facility: University of Alabama
state: Alabama
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: SSM Health SLU
state: Missouri
city: Pinehurst
country: United States
facility: FirstHealth Moore Regional Hospital
state: North Carolina
city: Toledo
country: United States
facility: JOBST Vascular Institute
state: Ohio
city: Orangeburg
country: United States
facility: Dialysis Access Institute
state: South Carolina
city: Richmond
country: United States
facility: Richmond Vascular
state: Virginia
Study officials:
affiliation: Dialysis Access Institute
name: John Aruny, MD
role: PRINCIPAL_INVESTIGATOR
References: