The Solaris DE Sirolimus-Eluting Covered Stent for the Treatment of AV Access Stenosis or Occlusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorScitech Produtos Medicos SA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, aged ≥ 18 years on the date of inclusion.
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.
Subject has clinical and/or hemodynamic evidence of a venous flow obstruction or AV fistula or graft dysfunction.
Provides written informed consent prior to any study-specific procedures.
Disqualifiers
Pregnant, breastfeeding or intending to become pregnant in the next year.
Presents with any planned major endovascular or surgical procedure (including in the access loop) within 30 days of the initial procedure.
Planned surgical revision of the access site.
Known or suspected hemodialysis access site infection, systemic infection, and/or septicemia.
Trial design
Design model
Parallel
Treatments tested in this trial
Solaris DE
DevicePercutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (75μg of Sirolimus) implantation in the treated vessel.
PTA
DevicePercutaneous Transluminal Angioplasty (PTA) in the treated vessel alone.
Solaris DE (200)
DevicePercutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (200μg of Sirolimus) implantation in the treated vessel.
Treatment groups
160 Participants
are divided into 4 treatment groupsGroup A: AVF TreatmentExperimental treatment 1 intervention
Group B: AVF ControlSham comparator 1 intervention
Group C: AVG TreatmentExperimental treatment 1 intervention
Group D: AVF/ AVG TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety Events
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).
Time frame
30 days2
Target Lesion Primary Patency (TLPP)
Percentage of participants without restenosis or clinically indicated target lesion revascularization or thrombosis.
Time frame
6 monthsSecondary outcomes
1
Target Lesion Primary Patency (TLPP)
Percentage of participants without restenosis or clinically indicated target lesion revascularization or thrombosis.
Time frame
12 and 24 months2
Assisted Target Lesion Primary Patency (aTLPP)
Percentage of participants without uncorrectable occlusion of the target lesion since the procedure.
Time frame
1, 6, 12 and 24 months3
Access Circuit Primary Patency (ACPP)
Percentage of participants without any new venous outflow circuit intervention, thrombosis or access abandonment since the procedure.
Time frame
1, 6, 12 and 24 months4
Cumulative Patency (CP)
Percentage of participants without the access circuit abandonment since the procedure.
Time frame
1, 6, 12 and 24 monthsSponsors and contacts
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Source ClinicalTrials.gov