RecruitingNot Applicable

The Solaris DE Endoprosthesis for the Treatment of AV Access Stenosis or Occlusion

Brazil120 participantsStarted 2024-08-30

Plain-language summary

The goal of this clinical trial is to demonstrate the safety and efficacy of Solaris DE Endoprosthesis in the treatment of stenosis or occlusion within the outflow circuit of the dialysis access including arteriovenous (AV) fistula and synthetic AV graft. Participants will be treated with Solaris DE Endoprosthesis. Researchers will compare the treatment with investigational product to Percutaneous Transluminal Angioplasty (PTA) alone within the AV fistula cohort in order to demonstrate superiority of Solaris DE.

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

. In one arm (including the cephalic arch) in a participant with AVF, and not in the cannulation segment, OR
. In the anastomosis or juxta-anastomosis in a participant with AVF (a juxta-anastomosis is defined as a location where the stent crosses the venous anastomosis)

Exclusion criteria

. Through the elbow
. In a region that causes bending of the endoprosthesis or bony protrusion over it
. In the cannulation segment (needling zone)
. Inside any part of a pre-existing stent or endoprosthesis (apart from an access arteriovenous graft)

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

Safety Events

Timeframe: 30 days

Target Lesion Primary Patency (TLPP)

Timeframe: 6 months

Trial details

NCT IDNCT06096142

SponsorScitech Produtos Medicos SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Luciano A Curado

+55 62 3625-5027 lcurado@scitechmed.com

View on ClinicalTrials.gov More Venous Stenosis trials