Effect of Amplifi Vein Dilation System Treatment on Radiocephalic AVF Maturation-3 (NCT07058610) | Clinical Trial Compass
CompletedNot Applicable
Effect of Amplifi Vein Dilation System Treatment on Radiocephalic AVF Maturation-3
Paraguay19 participantsStarted 2020-12-08
Plain-language summary
This multi-phase clinical study evaluated the safety and performance of the Amplifi Vein Dilation System (Amplifi System) in subjects requiring arteriovenous fistula (AVF) creation. Conducted at a single site outside the United States, subjects were enrolled across multiple phases. The study focused on device-related safety, procedural success, percent change in vein dilation and AVF maturation outcomes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Age ≥ 18 years
* Indicated for wrist or distal forearm radiocephalic AVF creation based on Investigator's standard practice
* ESRD currently receiving maintenance hemodialysis via a tunneled, cuffed hemodialysis catheter
* Baseline wrist or distal forearm cephalic vein diameter of \>= 1.7 mm and \< 3.2 mm at the proposed Study AVF creation site, wherein the wrist or forearm cephalic vein at the proposed Study AVF creation site is suitable for Amplifi Distal Outflow Catheter placement and Amplifi System treatment, including:
* \>= 1.7 mm to \< 3.2 mm diameter of the wrist or forearm cephalic vein at the proposed Study AVF creation site;
* patency and continuity of blood flow from the proposed Study AVF creation site centrally to the upper arm at the elbow through at least one or more of: 1) the upper arm cephalic vein; 2) the median cubital vein to the upper arm basilic system; or 3) the perforator vein to the deep venous system; and
* no occlusion or stenosis \> 50% along the course of the forearm cephalic vein and at least one upper arm venous outflow up to the subclavian vein, as determined by duplex ultrasonography
* Estimated forearm hemodialysis needle cannulation zone length \> 18 cm after creation of the proposed Study AVF
* At least one patent internal jugular vein suitable for Amplifi Inflow Catheter insertion
* Subject has voluntarily signed written informed consent
Exclusion Criteria:
* Known allergy or hypersensitivity to any Amplifi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of AVF Maturation at 2 and 6 Weeks
Timeframe: From post AVF creation to end of 6 weeks follow-up.
2
Percent Change in Cephalic Vein Diameter and Blood Flow
Timeframe: From baseline, during Amplifi System treatment (minimum daily), and prior to Amplifi System removal and AVF creation]
3
Mean vein diameter of the cephalic vein and blood flow of brachial artery
Timeframe: 2 and 6 weeks post AVF creation
4
Percentage of subjects who experience an increase in the cephalic vein diameter of ≥2.7 mm from their baseline measurement, or an increase of >1 mm from baseline, following treatment with the Amplifi System.
Timeframe: From baseline measurement to intra-procedural assessment immediately prior to Amplifi System removal and AVF creation (same procedure day)
5
Rate of Occurrence of Major Device-Related Adverse Events
Timeframe: from device implantation and up to 30 days from device removal and AVF creation