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Clinical Trials/NCT04070365
NCT04070365
Completed
Not Applicable

FLEX Arteriovenous Access Registry

VentureMed Group Inc.10 sites in 1 country114 target enrollmentMay 28, 2018
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ConditionsPeripheral Artery DiseaseArteriovenous Fistula StenosisArteriovenous Graft Stenosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Artery Disease
Sponsor
VentureMed Group Inc.
Enrollment
114
Locations
10
Primary Endpoint
Anatomic Success
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
May 28, 2018
End Date
May 26, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •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 Criteria

  • •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.

Outcomes

Primary Outcomes

Anatomic Success

Time Frame: At the completion of the index procedure

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

Secondary Outcomes

  • Procedural Success(6 Months)
  • Access Secondary Patency(6, 9, and 12 Months)
  • Technical Success of the Device(At the index procedure)
  • Clinical Success(6 Months)
  • Circuit Primary Patency(6, 9, and Months)
  • Target Lesion Primary Patency(6, 9 and 12 Months)
  • Assisted Primary Patency(6, 9, and 12 Months)

Study Sites (10)

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