FLEX Arteriovenous Access Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-28

Study Completion Date

2022-05-26

Brief Summary

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

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Detailed Description

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Conditions

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Peripheral Artery Disease Arteriovenous Fistula Stenosis Arteriovenous Graft Stenosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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FLEX Vessel Prep followed by angioplasty

FLEX Vessel Prep System followed by angioplasty

Intervention Type DEVICE

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

Interventions

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FLEX Vessel Prep System followed by angioplasty

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

Intervention Type DEVICE

Other Intervention Names

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Balloon Angioplasty

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No