FLEX FIRST Registry Research Protocol

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

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-29

Study Completion Date

2025-08-04

Brief Summary

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Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities following 12 months post treatment.

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Detailed Description

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Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities in real-world subjects per the Institution's standard practice and at 1-, 6-, and 12-months following treatment.

Conditions

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Arteriovenous Fistula Arteriovenous Graft Fistula Arterial Occlusive Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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FLEX Vessel Prep followed by angioplasty

Eligible subjects will be treated with the FLEX Vessel Prep system followed by balloon angioplasty.

FLEX Vessel Prep System

Intervention Type DEVICE

The FLEX Vessel Prep System to create circumferential, continuous micro-incisions along the length of the stenosis by performing a retrograde pullback through the lesion.

Following FLEX, standard balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding Instructions for Use. Once advanced into the lesion, the balloon should be inflated according to the site's standard of care.

Interventions

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FLEX Vessel Prep System

The FLEX Vessel Prep System to create circumferential, continuous micro-incisions along the length of the stenosis by performing a retrograde pullback through the lesion.

Following FLEX, standard balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding Instructions for Use. Once advanced into the lesion, the balloon should be inflated according to the site's standard of care.

Intervention Type DEVICE

Other Intervention Names

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Balloon Angioplasty

Eligibility Criteria

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Inclusion Criteria

1. Subject is ≥18 years of age.
2. Subject is currently scheduled to undergo an endovascular intervention of arteriovenous fistula or graft due to clinical and hemodynamic abnormalities meeting the KDOQI Guidelines for AV access dysfunction:

* Elevated venous pressure during hemodialysis,
* Abnormal physical findings, and
* Unexplained decrease in delivered dialysis dose.
3. Subject has a reasonable expectation of remaining on hemodialysis for ≥12 months.
4. Subject is legally competent, informed of the study, voluntarily agrees to participate, and signs the informed consent form.
5. Subject understands the study and is willing and able to comply with the follow-up requirements.

Exclusion Criteria

1. Subject has a known or suspected systemic infection.
2. Subject has a known or suspected infection of the hemodialysis graft.
3. Subject has an untreatable allergy to radiographic contrast material.
4. In the opinion of the operating physician, the subject's hemodialysis access is unsuitable for endovascular treatment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No