FLEX Arteriovenous Access Registry

VentureMed

Status: Completed

Conditions: Peripheral Artery Disease; Arteriovenous Fistula Stenosis; Arteriovenous Graft Stenosis

Treatments: Device: FLEX Vessel Prep System followed by angioplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT04070365

AV2019

Details and patient eligibility

About

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

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

114 participants in 1 patient group

FLEX Vessel Prep followed by angioplasty

Treatment:

Device: FLEX Vessel Prep System followed by angioplasty