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FLEX®-DCB Dialysis ACCESS Stenosis Study

NCT03566927 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-02-17

No results posted yet for this study

Summary

This prospective, single arm, single-center study is designed to evaluate the performance of the FLEX Scoring Catheter®/POBA/DCB in A-V access circuits.

Conditions

  • Arteriovenous Fistula

Interventions

COMBINATION_PRODUCT

FLEX Scoring Catheter with Lutonix DCB

Treatment by the FLEX Scoring Catheter, a plain balloon angioplasty, followed by a Lutonix DCB.

Sponsors & Collaborators

  • VentureMed Group Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-29
Primary Completion
2019-12-10
Completion
2019-12-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03566927 on ClinicalTrials.gov