Venous Stenosis, Venous Occlusion, Chronic Renal Failure
Conditions
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 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.
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 or occlusion of the venous outflow circuit. The study population includes two cohorts: * AVF cohort: participants presenting an arteriovenous fistula (AVF) stenosis or occlusion of the peripheral venous outflow circuit, including the cephalic arch, will be randomized 1:1 between treatment with the test device (Solaris DE) or standard treatment by Percutaneous Transluminal Angioplasty (PTA) alone); * AVG cohort: participants with an arteriovenous graft (AVG) presenting stenosis or occlusion at the graft vein anastomosis or juxta-anastomosis or at the segment of the prosthesis exit circuit, will be treated with the test device (Solaris DE) only.
Interventions
DEVICESolaris DE
Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE implantation in the treated vessel.
DEVICEPTA
Percutaneous Transluminal Angioplasty (PTA) in the treated vessel alone.
Sponsors
Scitech Produtos Medicos SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 distal reference 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 Inclusion Criteria: * The target lesion originates ≥ 3 cm from the cannulation segment (needling zone) * The target lesion is located: 1. In one arm (including the cephalic arch) in a participant with AVF, and not in the cannulation segment, OR 2. 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 distal 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 access 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 criteria
* 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) * The patient has a permanent central venous catheter (CVC) for dialysis access, except when its use is temporary, as a bridge to treatment through the access circuit, with a plan for removal after a successful dialysis session after the initial procedure Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Events | 30 days | Percentage of participants without any safety events affecting the access or venous outflow circuit and resulting in new intervention, hospitalization or death (not including stenosis or thrombosis). |
| Target Lesion Primary Patency (TLPP) | 6 months | Percentage of participants without restenosis or clinically indicated target lesion revascularization or thrombosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Access Circuit Primary Patency (ACPP) | 1, 6, 12 and 24 months | Percentage of participants without any new venous outflow circuit intervention, thrombosis or access abandonment since the procedure. |
| Cumulative Patency (CP) | 1, 6, 12 and 24 months | Percentage of participants without the access circuit abandonment since the procedure. |
| Procedure and device-related complications | 1, 6, 12 and 24 months | Complication rates related to the procedure and device involving the access circuit. |
| Target Lesion Primary Patency (TLPP) | 12 and 24 months | Percentage of participants without restenosis or clinically indicated target lesion revascularization or thrombosis. |
| Assisted Target Lesion Primary Patency (aTLPP) | 1, 6, 12 and 24 months | Percentage of participants without uncorrectable occlusion of the target lesion since the procedure. |
Countries
Brazil
Contacts
CONTACTLuciano A Curado
CONTACTAna Paula B Almeida, MSc.
PRINCIPAL_INVESTIGATORLeonardo O Harduin, MD
Hospital Universitário Pedro Ernesto - Universidade do Estado do Rio de Janeiro (HUPE-UERJ)
PRINCIPAL_INVESTIGATORLeonardo C Almeida, MD
Hospital Ana Nery
PRINCIPAL_INVESTIGATORThiago A Almeida, MD
Afya Hospital Dia LTDA
PRINCIPAL_INVESTIGATORDouglas E T Cavalcanti, MD
Real Hospital Português de Beneficência em Pernambuco
PRINCIPAL_INVESTIGATORGuilherme C Santos, MD
Hospital das Clínicas da UFMG/EBSERH
Outcome results
None listed