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FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF)
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
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Efficacy Endpoint: Target Lesion Primary Patency Rate
Primary Safety Endpoint: Serious Adverse Event Rate
Secondary study objectives
Access Circuit Primary Patency through 3 Months and 6 Months Post-Procedure
Balloon opening pressure
Clinical Success
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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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