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 Drug-Eluting Covered Stent (Solaris DE) 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. 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 in the treatment of hemodialysis patients with stenosis or occlusion of the venous outflow circuit. The study population includes three cohorts: * AVF cohort: subjects 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: subjects 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. * AVF/ AVG cohort: subjects with AVF/AVG for hemodialysis who have stenosis or occlusion of the periferic venous outflow circuit (including the cephalic arch and anastomosis of the graft vein or juxta-anastomosis) will be treated with Solaris DE (200).
Interventions
DEVICESolaris DE
Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (75μg of Sirolimus) implantation in the treated vessel.
DEVICEPTA
Percutaneous Transluminal Angioplasty (PTA) in the treated vessel alone.
DEVICESolaris DE (200)
Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (200μg of Sirolimus) implantation in the treated vessel.
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
1. Male or female, aged ≥ 18 years on the date of inclusion. 2. Has a mature AVF or AVG in the arm that was created ≥ 30 days before the initial procedure and is in use for dialysis therapy. 3. Subject has clinical and/or hemodynamic evidence of a venous flow obstruction or AV fistula or graft dysfunction. 4. Provides written informed consent prior to any study-specific procedures. 5. Is willing to submit to all follow-up evaluations accordingly with the specified schedule over 24 months. Angiographic Inclusion Criteria: 1. The target lesion is localized: 1. On an arm (including the cephalic arch) in an individual with AVF, and not on the cannulation segment (needling zone), OR 2. On anastomosis or juxta-anastomosis in an individual with VAS. The juxta-anastomosis is defined as a location such that the stent graft crosses the venous anastomosis. 2. The target lesion involves a de novo stenotic lesion or restenosis. 3. The target lesion is ≥ 5 cm from the arterial anastomosis. 4. The target lesion originates ≥ 3 cm of the cannulation segment (needling zone). 5. The target lesion has ≥ 50% stenosis by the operator's visual estimate. 6. The diameter of the distal reference vessel/graft is between 4.0 mm and 9.0 mm. 7. The target lesion should be ≤ 8 cm in total length by the operator's visual estimate. 8. Single or multiple target lesions may be covered by a single or two overlapping stents, provided that they are treated as a single lesion with a maximum length of 8 cm. 9. There was a successful predilation of the target lesion, defined as crossing the guidewire resulting in full expansion of the predilation balloon. 10. It presents 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. 11. The non-target lesion was successfully treated at the time of the initial procedure (success measured as ≤30% residual stenosis and no complications). 12. It does not have an endoprosthesis or has been in the access circuit for ≥ 30 days since placement and patent with ≤ 30% stenosis and is located ≥ 5 cm from the target lesion.
Exclusion criteria
1. Pregnant, breastfeeding or intending to become pregnant in the next year. 2. Presents with any planned major endovascular or surgical procedure (including in the access loop) within 30 days of the initial procedure. 3. Planned surgical revision of the access site. 4. Known or suspected hemodialysis access site infection, systemic infection, and/or septicemia. 5. Patients on immunosuppressive therapy. 6. Known active coagulopathy or bleeding diathesis. 7. Known hypersensitivity to nickel titanium alloy, contrast or Sirolimus. 8. Contraindication to antiplatelet, anticoagulant, or thrombolytic therapies. 9. Known allergy to contrast agents or medications administered to perform endovascular intervention that cannot be adequately premedicated. 10. Life expectancy less than 12 months. 11. It is anticipated that the individual's hemodialysis access will be abandoned within 6 months. 12. The patient is participating in another research study involving an investigational product (pharmaceutical, biologic, or medical device). 13. The patient has a permanent central venous catheter (CVC) for dialysis access, except when the use is temporary, as a bridge to treatment through the access circuit and there is 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 |
|---|---|---|
| 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. |
| 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. |
Countries
Brazil
Contacts
CONTACTMarco A Costa
CONTACTAna Paula B A Pellaquim
PRINCIPAL_INVESTIGATORLeonardo O Harduin, PhD
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