Status:
COMPLETED
FLEX Arteriovenous Access Registry
Lead Sponsor:
VentureMed Group Inc.
Conditions:
Peripheral Artery Disease
Arteriovenous Fistula Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
Evaluation of the FLEX Vessel Prep system combined with angioplasty in the treatment of arteriovenous access stenosis.
Eligibility Criteria
Inclusion
- Hemodialysis patient currently scheduled to undergo an intervention of their arteriovenous fistula or graft due to clinical or hemodynamic abnormalities.
- 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.
- The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
- The patient understands the study and is willing and able to comply with follow-up requirements.
- The patient is willing to provide informed consent.
Exclusion
- The patient has a known or suspected systemic infection.
- The patient has a known or suspected infection of the hemodialysis graft.
- The patient has an untreatable allergy to radiographic contrast material.
- In the opinion of the operating physician, the patient's hemodialysis access is unsuitable for endovascular treatment.
Key Trial Info
Start Date :
May 28 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 26 2022
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04070365
Start Date
May 28 2018
End Date
May 26 2022
Last Update
May 31 2022
Active Locations (10)
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1
Grandview Medical Center
Birmingham, Alabama, United States, 35243
2
Flowers Hospital
Dothan, Alabama, United States, 36305
3
University of Alabama
Tuscaloosa, Alabama, United States, 35487
4
University of Michigan
Ann Arbor, Michigan, United States, 48109