Status:
RECRUITING
The Solaris DE Endoprosthesis for the Treatment of AV Access Stenosis or Occlusion
Lead Sponsor:
Scitech Produtos Medicos Ltda
Conditions:
Venous Stenosis
Venous Occlusion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 inclu...
Detailed Description
This is a prospective, randomized (1:1), controlled, multicenter study to investigate the safety and efficacy of the Solaris DE Endoprosthesis in the treatment of hemodialysis patients with stenosis o...
Eligibility Criteria
Inclusion
- The participant has a mature AV Fistula (AVF) or Graft (AVG) in the arm created ≥ 30 days before the initial procedure and is in use for dialysis therapy
- The participant has clinical and/or hemodynamic evidence of a venous outflow obstruction or AV fistula or graft dysfunction. The stenotic lesion is ≥ 50%, with a maximum length of 8 cm and a vessel diameter from 4.0 mm to 9.0 mm
- The participan provides written informed consent prior to any study-specific procedure
- The participan is willing to undergo all follow-up evaluations according to the specified schedule over 24 months
- Angiographic
- The target lesion originates ≥ 3 cm from the cannulation segment (needling zone)
- The target lesion is located:
- 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)
- The target lesion includes a de novo stenotic lesion or restenosis
- The target lesion is ≥ 5 cm from the arterial anastomosis
- The target lesion has ≥ 50% stenosis according to the operator's visual judgment
- The reference vessel diameter of the target lesion is between 4.0 mm and 9.0 mm by the operator's visual judgment
- Single or multiple target lesions measuring ≤ 8 cm in total length by the operator's visual judgment
- Single or multiple target lesions should be covered by a single stent or multiple overlapping stents, provided they are treated as a single lesion with a maximum length of 8 cm
- Successful target lesion pre-dilatation is defined as crossover of the guidewir resulting in full expansion of the pre-dilatation balloon
- The participant has up to 1 (one) non-target lesion in the venous outflow circuit requiring intervention in the initial procedure. The non-target lesion must be at least 10 cm away from the target lesion. The non-target lesion can only be treated with standard PTA alone
- Does not have stent implanted or it has been in the access circuit for ≥ 30 days since placement and patent with ≤ 30% stenosis and located ≥ 5 cm from the target lesion
- The non-target lesion must be successfully treated at the time of the initial procedure (success measured as ≤30% residual stenosis and no complications).
Exclusion
- Pregnant, breastfeeding or with intention to become pregnant in the next year
- The participant has any major endovascular or surgical procedure planned (including in the access circuit) within 30 days of the initial procedure
- It was not possible to pre-dilate the lesion to be treated with Solaris DE
- Planned surgical revision of the access site
- Known or suspected infection of the hemodialysis access site, systemic infection and/or sepsis
- Patients on immunosuppressive therapy
- Known active coagulopathy or bleeding diathesis
- Known hypersensitivity to nickel titanium alloy, contrast or sirolimus
- Contraindication to antiplatelet, anticoagulant or thrombolytic therapies
- Known allergy to contrast agents or medications administered to perform endovascular intervention that cannot be adequately premedicated
- Life expectancy of less than 12 months
- Has a stent or endoprosthesis located anywhere in the AV access circuit that is not patent (\> 30% stenosis) or implanted \< 30 days
- The participant's hemodialysis access is expected to be abandoned within 6 months
- The participantis is enrolled in another trial involving an investigational product (pharmaceutical, biological or medical device)
- Angiographic
Key Trial Info
Start Date :
August 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06096142
Start Date
August 30 2024
End Date
February 1 2028
Last Update
May 15 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Ana Nery
Salvador, Estado de Bahia, Brazil, 40323-010
2
Afya Hospital Dia LTDA
Brasília, Federal District, Brazil, 70390-150
3
Hospital das Clínicas da UFMG/EBSERH
Belo Horizonte, Minas Gerais, Brazil, 30130-100
4
Real Hospital Português de Beneficência em Pernambuco
Recife, Pernambuco, Brazil, 52010-160