The Solaris DE Endoprosthesis 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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Solaris DE
DevicePercutaneous Transluminal Angioplasty (PTA) followed by Solaris DE implantation in the treated vessel.
PTA
DevicePercutaneous Transluminal Angioplasty (PTA) in the treated vessel alone.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: AVF TreatmentExperimental treatment 1 intervention
Group B: AVF ControlSham comparator 1 intervention
Group C: 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