Actively Recruiting
The Solaris DE Endoprosthesis for the Treatment of AV Access Stenosis or Occlusion
Led by Scitech Produtos Medicos SA · Updated on 2026-03-17
120
Participants Needed
5
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Solaris DE Endoprosthesis for the Treatment of AV Access Stenosis or Occlusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has a mature arteriovenous fistula (AVF) or graft (AVG) in the arm created 30 or more days before the procedure and used for dialysis
- Clinical or hemodynamic evidence of venous outflow obstruction or AV fistula/graft dysfunction with stenosis 50% or greater
- Stenotic lesion maximum length is 8 cm with distal vessel diameter between 4.0 mm and 9.0 mm
- Provides written informed consent before any study procedures
- Willing to complete all follow-up visits over 24 months
- Target lesion originates at least 3 cm from the cannulation (needling) segment
- Target lesion located in the arm including cephalic arch for AVF, or in anastomosis or juxta-anastomosis for AVF
- Target lesion is a new stenosis or restenosis
- Target lesion is at least 5 cm from the arterial anastomosis
- Target lesion has at least 50% stenosis by operator's visual judgment
- Distal reference vessel diameter of target lesion is 4.0 to 9.0 mm by operator's visual judgment
- Single or multiple target lesions total 8 cm or less and can be covered by single or overlapping stents
- Successful pre-dilatation of target lesion by balloon angioplasty
- Up to one non-target lesion in access circuit allowed, treated with PTA only, at least 10 cm from target lesion
- No stent implanted in access circuit or stent implanted 30 or more days ago and patent with 30% or less stenosis and at least 5 cm from target lesion
- Non-target lesion successfully treated at initial procedure with 30% or less residual stenosis and no complications
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy within one year
- Major endovascular or surgical procedure planned within 30 days of initial procedure
- Unable to pre-dilate lesion for Solaris DE treatment
- Planned surgical revision of access site
- Known or suspected infection of dialysis access site, systemic infection, or sepsis
- On immunosuppressive therapy
- Known active bleeding disorder or coagulopathy
- Known hypersensitivity to nickel titanium alloy, contrast, or sirolimus
- Contraindication to antiplatelet, anticoagulant, or thrombolytic therapies
- Known allergy to contrast agents or medications used in endovascular intervention that cannot be premedicated
- Life expectancy less than 12 months
- Non-patent stent or endoprosthesis in AV access circuit or stent implanted less than 30 days ago
- Expected abandonment of hemodialysis access within 6 months
- Enrolled in another trial with investigational product
- Has permanent central venous catheter for dialysis access unless temporary bridge with plan for removal after successful dialysis
- Target lesion inside endoprosthesis
- Target lesion involves cannulation segment
- Target lesion less than 5 cm from arterial anastomosis
- Vessel dissection or rupture during treatment that could not be controlled
- Aneurysm, pseudoaneurysm, or acute thrombus within target lesion
- Target lesion or Solaris DE placement through elbow, bending area, cannulation segment, inside pre-existing stent or endoprosthesis (except AV graft), lower extremity, non-synthetic graft, or proximal central thoracic veins
- Target lesion location causing stent kink requiring bridging stent
- More than one non-target lesion requiring intervention at initial procedure
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Hospital Ana Nery
Salvador, Estado de Bahia, Brazil, 40323-010
Actively Recruiting
2
Afya Hospital Dia LTDA
Brasília, Federal District, Brazil, 70390-150
Actively Recruiting
3
Hospital das Clínicas da UFMG/EBSERH
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Actively Recruiting
4
Real Hospital Português de Beneficência em Pernambuco
Recife, Pernambuco, Brazil, 52010-160
Actively Recruiting
5
Hospital Universitário Pedro Ernesto - UERJ
Rio de Janeiro, Rio de Janeiro, Brazil, 20551030
Actively Recruiting
Research Team
L
Luciano A Curado
CONTACT
A
Ana Paula B Almeida, MSc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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