Venous StenosisDEScoverNCT06096142
The Solaris DE Sirolimus-Eluting Covered Stent for the Treatment of AV Access Stenosis or Occlusion
A study testing Solaris DE, PTA and Solaris DE (200) in people with Venous Stenosis and Venous Occlusion, run by Scitech Produtos Medicos SA at 5 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Stenosis, Venous Occlusion, Chronic Renal Failure
- What is being tested?
- Solaris DE, PTA and Solaris DE (200)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 5 sitesBrazil
- Study dates
- 30 Aug 2024to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Is willing to submit to all follow-up evaluations accordingly with the specified schedule over 24 months.
- Angiographic Inclusion Criteria:
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- The target lesion is localized:
- On an arm (including the cephalic arch) in an individual with AVF, and not on the cannulation segment (needling zone), OR
- 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.
- The target lesion involves a de novo stenotic lesion or restenosis.
- The target lesion is ≥ 5 cm from the arterial anastomosis.
- The target lesion originates ≥ 3 cm of the cannulation segment (needling zone).
- The target lesion has ≥ 50% stenosis by the operator's visual estimate.
- The diameter of the distal reference vessel/graft is between 4.0 mm and 9.0 mm.
- The target lesion should be ≤ 8 cm in total length by the operator's visual estimate.
- 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.
- There was a successful predilation of the target lesion, defined as crossing the guidewire resulting in full expansion of the predilation balloon.
- 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.
- The non-target lesion was successfully treated at the time of the initial procedure (success measured as ≤30% residual stenosis and no complications).
- 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.
Who cannot join
- 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.
- Patients on immunosuppressive therapy.
- Known active coagulopathy or bleeding diathesis.
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- 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 less than 12 months.
- It is anticipated that the individual's hemodialysis access will be abandoned within 6 months.
- The patient is participating in another research study involving an investigational product (pharmaceutical, biologic, or medical device).
- 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 Exclusion Criteria:
- Has a stent or stent graft located at any point in the AV access circuit that is not patent (> 30% stenosis) or implanted < 30 days.
- The target lesion is < 5 cm from the arterial anastomosis.
- It was not possible to perform predilation of the target lesion to be treated with Solaris DE.
- There was dissection/rupture of the treated vessel during the initial treatment that could not be controlled.
- There is evidence of an aneurysm, pseudoaneurysm, or acute thrombus in the target lesion. (Note: The aneurysm or pseudoaneurysm present at the access but outside the target lesion can be treated during the initial procedure. Patients with acute thrombus can only be included after 15 days of thrombus treatment).
- The target lesion is, and/or Solaris DE would be placed anywhere:
- In the elbow region and joint
- In a region that causes bending of the stent graft or bone protrusion over it
- In the cannulation segment (needling zone)
- Within any part of a pre-existing stent/stent graft (except for the arteriovenous graft of the access)
- Lower End
- Non-synthetic graft
- Central thoracic veins located proximally to the arch of the cephalic vein.
- The subject has more than one (1) non-target lesion (≥ 50% stenosis) that requires intervention in the initial procedure.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Brazil5 sites, 5 recruiting
- Recruiting
Hospital das Clínicas da UFMG/EBSERH
Belo Horizonte, Minas Gerais, 30130-100
Guilherme Castro, MD
Guilherme Castro, MD
- Recruiting
Afya Hospital Dia LTDA
Brasília, Federal District, 70390-150
Thiago A Barroso, MD
Thiago Barroso, MD
- Recruiting
Real Hospital Português de Beneficência em Pernambuco
Recife, Pernambuco, 52010-160
Douglas Cavacanti, MD
Douglas Cavalcanti, MD
- Recruiting
Hospital Universitário Pedro Ernesto - UERJ
Rio de Janeiro, Rio de Janeiro, 20551030
Leonardo O Harduin, MD
Leonardo O Harduin, MD
- Recruiting
Hospital Ana Nery
Salvador, Estado de Bahia, 40323-010
Leonardo Cortizo, MD
Leonardo Cortizo, MD
About this study
Official title: Prospective, Randomized, Controlled, Multicenter Study of the Solaris DE Sirolimus-Eluting Covered Stent in the Treatment of Venous Outflow Stenosis or Occlusion in Hemodialysis Patients
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.
Read the 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).
- Conditions
- Venous Stenosis, Venous Occlusion, Chronic Renal Failure
- Being tested
- Solaris DE, PTA, Solaris DE (200)
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solaris DEDevice
Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (75μg of Sirolimus) implantation in the treated vessel.
PTADevice
Percutaneous Transluminal Angioplasty (PTA) in the treated vessel alone.
Solaris DE (200)Device
Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (200μg of Sirolimus) implantation in the treated vessel.
| Study group | Role | What they receive |
|---|---|---|
| AVF Treatment | Experimental | Participants on dialysis via AV fistula will be treated with percutaneous transluminal angioplasty (PTA) followed by Solaris DE implantation. Receives: Device: Solaris DE |
| AVF Control | Sham comparator | Participants on dialysis via AV fistula will be treated with percutaneous transluminal angioplasty (PTA) alone. Receives: Device: PTA |
| AVG Treatment | Experimental | Participants on dialysis via AV graft will be treated with percutaneous transluminal angioplasty (PTA) followed by Solaris DE implantation. Receives: Device: Solaris DE |
| AVF/ AVG Treatment | Experimental | Participants on dialysis via AV fistula or graft will be treated with percutaneous transluminal angioplasty (PTA) followed by Solaris DE (200) implantation. Receives: Device: Solaris DE (200) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days
Target Lesion Primary Patency (TLPP)
Percentage of participants without restenosis or clinically indicated target lesion revascularization or thrombosis.
Measured: 6 months
Secondary outcomes (5)
Target Lesion Primary Patency (TLPP)
Percentage of participants without restenosis or clinically indicated target lesion revascularization or thrombosis.
Measured: 12 and 24 months
Assisted Target Lesion Primary Patency (aTLPP)
Percentage of participants without uncorrectable occlusion of the target lesion since the procedure.
Measured: 1, 6, 12 and 24 months
Access Circuit Primary Patency (ACPP)
Percentage of participants without any new venous outflow circuit intervention, thrombosis or access abandonment since the procedure.
Measured: 1, 6, 12 and 24 months
Cumulative Patency (CP)
Percentage of participants without the access circuit abandonment since the procedure.
Measured: 1, 6, 12 and 24 months
Procedure and device-related complications
Complication rates related to the procedure and device involving the access circuit.
Measured: 1, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start30 Aug 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scitech Produtos Medicos SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leonardo O Harduin, PhD, Principal investigator, Hospital Universitário Pedro Ernesto - Universidade do Estado do Rio de Janeiro (HUPE-UERJ)Leonardo C Almeida, MD, Principal investigator, Hospital Ana NeryThiago A Almeida, MD, Principal investigator, Afya Hospital Dia LTDADouglas E T Cavalcanti, MD, Principal investigator, Real Hospital Português de Beneficência em PernambucoGuilherme C Santos, MD, Principal investigator, Hospital das Clínicas da UFMG/EBSERH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096142
- Sponsor's protocol ID
- SCI-SD-001
- Acronym
- DEScover
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled, Multicenter Study of the Solaris DE Sirolimus-Eluting Covered Stent in the Treatment of Venous Outflow Stenosis or Occlusion in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06096142
- Acronym / sponsor ID
- DEScover / SCI-SD-001
- Conditions
- Venous Stenosis, Venous Occlusion, Chronic Renal Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Scitech Produtos Medicos SAIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AVF Treatment | Experimental | Device: Solaris DEParticipants on dialysis via AV fistula will be treated with percutaneous transluminal angioplasty (PTA) followed by Solaris DE implantation. |
| AVF Control | Sham comparator | Device: PTAParticipants on dialysis via AV fistula will be treated with percutaneous transluminal angioplasty (PTA) alone. |
| AVG Treatment | Experimental | Device: Solaris DEParticipants on dialysis via AV graft will be treated with percutaneous transluminal angioplasty (PTA) followed by Solaris DE implantation. |
| AVF/ AVG Treatment | Experimental | Device: Solaris DE (200)Participants on dialysis via AV fistula or graft will be treated with percutaneous transluminal angioplasty (PTA) followed by Solaris DE (200) implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
- Is willing to submit to all follow-up evaluations accordingly with the specified schedule over 24 months.
Key exclusion criteria (28 listed)
- 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.
- Patients on immunosuppressive therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solaris DEPercutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (75μg of Sirolimus) implantation in the treated vessel. | Device | AVF Treatment, AVG Treatment |
| PTAPercutaneous Transluminal Angioplasty (PTA) in the treated vessel alone. | Device | AVF Control |
| Solaris DE (200)Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (200μg of Sirolimus) implantation in the treated vessel. | Device | AVF/ AVG Treatment |
Primary outcome
Safety Events
Time frame: 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)
Time frame: 6 months
Percentage of participants without restenosis or clinically indicated target lesion revascularization or thrombosis.
5 secondary outcomes
Target Lesion Primary Patency (TLPP)
Time frame: 12 and 24 months
Assisted Target Lesion Primary Patency (aTLPP)
Time frame: 1, 6, 12 and 24 months
Access Circuit Primary Patency (ACPP)
Time frame: 1, 6, 12 and 24 months
Cumulative Patency (CP)
Time frame: 1, 6, 12 and 24 months
Procedure and device-related complications
Time frame: 1, 6, 12 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leonardo O Harduin, PhD principal investigator
Hospital Universitário Pedro Ernesto - Universidade do Estado do Rio de Janeiro (HUPE-UERJ)
Leonardo C Almeida, MD principal investigator
Hospital Ana Nery
Thiago A Almeida, MD principal investigator
Afya Hospital Dia LTDA
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solaris DE, PTA and Solaris DE (200) in people with Venous Stenosis and Venous Occlusion, run by Scitech Produtos Medicos SA at 5 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco A Costa (+55 62 3625-3751, marco.costa@scitechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Events (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.