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FLEX Vessel Prep System followed with PTA (TEST arm) for Arteriovenous Fistula Stenosis

N/A
Waitlist Available
Research Sponsored by VentureMed Group Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 6 months
Awards & highlights

Study Summary

This trial is testing whether adding a device to angioplasty (PTA) for treating blockages in native arteriovenous dialysis fistulae is better than PTA alone.

Eligible Conditions
  • Arteriovenous Fistula Stenosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Efficacy Endpoint: Target Lesion Primary Patency Rate
Primary Safety Endpoint: Serious Adverse Event Rate
Secondary outcome measures
Access Circuit Primary Patency through 3 Months and 6 Months Post-Procedure
Balloon opening pressure
Clinical Success
+10 more

Trial Design

2Treatment groups
Active Control
Group I: FLEX Vessel Prep System followed with PTA (TEST arm)Active Control1 Intervention
FLEX Vessel Prep System is used 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 to the lesion, the balloon should be inflated according to the site's standard of care.
Group II: PTA only (CONTROL arm)Active Control1 Intervention
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 to the lesion, the balloon should be inflated according to the site's standard of care.

Find a Location

Who is running the clinical trial?

VentureMed Group Inc.Lead Sponsor
5 Previous Clinical Trials
707 Total Patients Enrolled
1 Trials studying Arteriovenous Fistula Stenosis
114 Patients Enrolled for Arteriovenous Fistula Stenosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF)
2021. "FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05034939.
~21 spots leftby Apr 2025
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