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RecruitingNCT06096142DEScoverUpdated Oct 6, 2026

The Solaris DE Sirolimus-Eluting Covered Stent for the Treatment of AV Access Stenosis or Occlusion

An interventional study of Solaris DE and PTA in Venous Stenosis, Venous Occlusion and Chronic Renal Failure, sponsored by Scitech Produtos Medicos SA. Recruiting at 5 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Scitech Produtos Medicos SA · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 2 months later.
Updated Oct 6, 2026Primary completion movedStudy completion moved+5 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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).
02

Conditions studied

  • Venous Stenosis
  • Venous Occlusion
  • Chronic Renal Failure
03

In context

Kidney Failure, Chronic

2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.

This study's planned enrollment of 160 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Scitech Produtos Medicos SA is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 6, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 therapy.
  6. Known active coagulopathy or bleeding diathesis.
  7. Known to nickel titanium alloy, contrast or Sirolimus.
  8. 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. 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 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 Exclusion Criteria:

  1. 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.
  2. The target lesion is \< 5 cm from the arterial anastomosis.
  3. It was not possible to perform predilation of the target lesion to be treated with Solaris DE.
  4. There was dissection/rupture of the treated vessel during the initial treatment that could not be controlled.
  5. 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).

  6. The target lesion is, and/or Solaris DE would be placed anywhere:

    1. In the elbow region and joint
    2. In a region that causes bending of the stent graft or bone protrusion over it
    3. In the cannulation segment (needling zone)
    4. Within any part of a pre-existing stent/stent graft (except for the arteriovenous graft of the access)
    5. Lower End
    6. Non-synthetic graft
    7. Central thoracic veins located proximally to the arch of the cephalic vein.
  7. The subject has more than one (1) non-target lesion (≥ 50% stenosis) that requires intervention in the initial procedure.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    AVF Treatment

    Participants on dialysis via AV fistula will be treated with percutaneous transluminal angioplasty (PTA) followed by Solaris DE implantation.

    Device: Solaris DE

  • Sham comparator
    AVF Control

    Participants on dialysis via AV fistula will be treated with percutaneous transluminal angioplasty (PTA) alone.

    Device: PTA

  • Experimental
    AVG Treatment

    Participants on dialysis via AV graft will be treated with percutaneous transluminal angioplasty (PTA) followed by Solaris DE implantation.

    Device: Solaris DE

  • Experimental
    AVF/ AVG Treatment

    Participants on dialysis via AV fistula or graft will be treated with percutaneous transluminal angioplasty (PTA) followed by Solaris DE (200) implantation.

    Device: 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.

06

What researchers measure

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 days

  2. Target Lesion Primary Patency (TLPP)

    Percentage of participants without restenosis or clinically indicated target lesion revascularization or thrombosis.

    Time frame: 6 months

Secondary 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 months

  2. 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 months

  3. 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 months

  4. Cumulative Patency (CP)

    Percentage of participants without the access circuit abandonment since the procedure.

    Time frame: 1, 6, 12 and 24 months

  5. Procedure and device-related complications

    Complication rates related to the procedure and device involving the access circuit.

    Time frame: 1, 6, 12 and 24 months

07

Study locations

5 of 5 sites recruiting
  • Hospital Ana Nery
    Salvador, Estado de Bahia 40323-010, Brazil
    Recruiting
    • Leonardo Cortizo, MD · Contact
    • Leonardo Cortizo, MD · Principal investigator
  • Afya Hospital Dia LTDA
    Brasília, Federal District 70390-150, Brazil
    Recruiting
    • Thiago A Barroso, MD · Contact
    • Thiago Barroso, MD · Principal investigator
  • Hospital das Clínicas da UFMG/EBSERH
    Belo Horizonte, Minas Gerais 30130-100, Brazil
    Recruiting
    • Guilherme Castro, MD · Contact
    • Guilherme Castro, MD · Principal investigator
  • Real Hospital Português de Beneficência em Pernambuco
    Recife, Pernambuco 52010-160, Brazil
    Recruiting
    • Douglas Cavacanti, MD · Contact
    • Douglas Cavalcanti, MD · Principal investigator
  • Hospital Universitário Pedro Ernesto - UERJ
    Rio de Janeiro, Rio de Janeiro 20551030, Brazil
    Recruiting
    • Leonardo O Harduin, MD · Contact
    • Leonardo O Harduin, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2024 (actual). Primary completion is estimated for Oct 2027, 37 months after the start.

Of 78 industry-sponsored interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 40. This study's planned 37 months is above that.

Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 6, 2026: primary completion Aug 2026 → Oct 2027 and completion Feb 2028 → Apr 2029.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 17, 2023
First posted
Oct 23, 2023
StartActual
Aug 30, 2024
Primary completionEst.
Oct 1, 2027was Aug 2026
CompletionEst.
Apr 30, 2029was Feb 2028
Last update
Oct 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Aug 2026→Oct 1, 2027
Oct 6, 2026
Study completion
Feb 2028→Apr 30, 2029
Oct 6, 2026
Enrollment
120→160
Oct 6, 2026
Eligibility
17 inclusion criteria edited, 1 added; 18 exclusion criteria edited, 3 removed
What changed in the criteria
Inclusion criteria
  • AddedMale or female, aged ≥ 18 years on the date of inclusion.
  • EditedThe participant hasHas a mature AV Fistula (AVF) or Graft (AVG) in the arm that was created ≥ 30 days before the initial procedure and is in use for dialysis therapy.
  • EditedThe participantSubject has clinical and/or hemodynamic evidence of a venous outflowflow 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
  • EditedThe participan providesProvides written informed consent prior to any study-specific procedureprocedures.
  • EditedThe participan isIs willing to undergosubmit to all follow-up evaluations according toaccordingly with the specified schedule over 24 months.
  • EditedThe target lesion is locatedlocalized:
  • EditedIn oneOn an arm (including the cephalic arch) in a participantan individual with AVF, and not inon the cannulation segment (needling zone), OR
  • EditedIn theOn anastomosis or juxta-anastomosis in a participantan individual with AVF (aVAS. The juxta-anastomosis is defined as a location wheresuch that the stent graft crosses the venous anastomosis).
  • EditedThe target lesion includesinvolves a de novo stenotic lesion or restenosis.
  • EditedThe target lesion originates ≥ 3 cm fromof the cannulation segment (needling zone).
  • EditedThe target lesion has ≥ 50% stenosis according toby the operator's visual judgmentestimate.
  • EditedThe distal reference vessel diameter of the target lesiondistal reference vessel/graft is between 4.0 mm and 9.0 mm by the operator's visual judgment.
  • EditedSingle or multipleThe target lesions measuringlesion should be ≤ 8 cm in total length by the operator's visual judgmentestimate.
  • EditedSingle or multiple target lesions shouldmay be covered by a single stent or multipletwo overlapping stents, provided that they are treated as a single lesion with a maximum length of 8 cm.
  • EditedSuccessfulThere was a successful predilation of the target lesion pre-dilatation is, defined as crossover ofcrossing the guidewirguidewire resulting in full expansion of the pre-dilatationpredilation balloon.
  • EditedThe participant hasIt 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 alone.
  • EditedThe non-target lesion must bewas successfully treated at the time of the initial procedure (success measured as ≤30% residual stenosis and no complications).
  • EditedDoesIt does not have stent implantedan endoprosthesis or it 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
  • EditedPregnant, breastfeeding or with intentionintending to become pregnant in the next year.
  • EditedThe participant hasPresents with any planned major endovascular or surgical procedure planned (including in the access circuitloop) within 30 days of the initial procedure.
  • EditedKnown or suspected infection of the hemodialysis access site infection, systemic infection, and/or sepsissepticemia.
  • EditedContraindication to antiplatelet, anticoagulant, or thrombolytic therapies.
  • EditedLife expectancy of less than 12 months.
  • EditedThe participantIt is anticipated that the individual's hemodialysis access is expected towill be abandoned within 6 months.
  • EditedThe participantispatient is enrolledparticipating in another trialresearch study involving an investigational product (pharmaceutical, biologicalbiologic, or medical device).
  • EditedThe patient has a permanent central venous catheter (CVC) for dialysis access, except when itsthe use is temporary, as a bridge to treatment through the access circuit, with and there is a plan for removal after a successful dialysis session after the initial procedure.
  • RemovedThe target lesion is located inside an endoprosthesis
  • RemovedTarget lesion treatment would involve the cannulation segment (needling zone)
  • EditedHas a stent or endoprosthesisstent graft located anywhereat any point in the AV access circuit that is not patent (> 30% stenosis) or implanted < 30 days.
  • EditedIt was not possible to pre-dilateperform predilation of the target lesion to be treated with Solaris DE.
  • EditedThere was a dissection or /rupture of the treated vessel during the initial treatment that could not be controlled.
  • ChangedBefore Evidence of an aneurysm, pseudoaneurysm or acute thrombus (i.e. one that has been treated ≤ 15 days) within the target lesionNow 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).
  • ChangedBefore Through the elbowNow In the elbow region and joint
  • EditedIn a region that causes bending of the endoprosthesisstent graft or bonybone protrusion over it
  • EditedInsideWithin any part of a pre-existing stent or endoprosthesis/stent graft (apart from an accessexcept for the arteriovenous graft of the access)
  • EditedLower extremityEnd
  • EditedCentral thoracic veins located proximalproximally to the arch of the cephalic vein arch.
  • RemovedThe target lesion is located in such a way that the insertion of a stent would result in a "kink" area that requires a stent bridge between the Solaris DE and an existing stent or stent graft
  • EditedThe individualsubject has more than 1one (one1) non-target lesion (≥ 50% stenosis) that requires intervention in the initial procedure.
Oct 6, 2026
Interventions
Added Device: Solaris DE (200). Arms added: AVF/ AVG Treatment
Oct 6, 2026
Contact
Study contact changed: l•••@scitechmed.com · •••5027→m•••@scitechmed.com · •••3751; a•••@scitechmed.com · •••5027→a•••@scitechmed.com · •••3751. See the current contact
Oct 6, 2026
Title
The Solaris DE EndoprosthesisSirolimus-Eluting Covered Stent for the Treatment of AV Access Stenosis or Occlusion
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Primary completion Aug 2026→Oct 1, 2027
    Study completion Feb 2028→Apr 30, 2029
    Enrollment 120→160
    Eligibility 17 inclusion criteria edited, 1 added; 18 exclusion criteria edited, 3 removed
    What changed in the criteria
    Inclusion criteria
    • AddedMale or female, aged ≥ 18 years on the date of inclusion.
    • EditedThe participant hasHas a mature AV Fistula (AVF) or Graft (AVG) in the arm that was created ≥ 30 days before the initial procedure and is in use for dialysis therapy.
    • EditedThe participantSubject has clinical and/or hemodynamic evidence of a venous outflowflow 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
    • EditedThe participan providesProvides written informed consent prior to any study-specific procedureprocedures.
    • EditedThe participan isIs willing to undergosubmit to all follow-up evaluations according toaccordingly with the specified schedule over 24 months.
    • EditedThe target lesion is locatedlocalized:
    • EditedIn oneOn an arm (including the cephalic arch) in a participantan individual with AVF, and not inon the cannulation segment (needling zone), OR
    • EditedIn theOn anastomosis or juxta-anastomosis in a participantan individual with AVF (aVAS. The juxta-anastomosis is defined as a location wheresuch that the stent graft crosses the venous anastomosis).
    • EditedThe target lesion includesinvolves a de novo stenotic lesion or restenosis.
    • EditedThe target lesion originates ≥ 3 cm fromof the cannulation segment (needling zone).
    • EditedThe target lesion has ≥ 50% stenosis according toby the operator's visual judgmentestimate.
    • EditedThe distal reference vessel diameter of the target lesiondistal reference vessel/graft is between 4.0 mm and 9.0 mm by the operator's visual judgment.
    • EditedSingle or multipleThe target lesions measuringlesion should be ≤ 8 cm in total length by the operator's visual judgmentestimate.
    • EditedSingle or multiple target lesions shouldmay be covered by a single stent or multipletwo overlapping stents, provided that they are treated as a single lesion with a maximum length of 8 cm.
    • EditedSuccessfulThere was a successful predilation of the target lesion pre-dilatation is, defined as crossover ofcrossing the guidewirguidewire resulting in full expansion of the pre-dilatationpredilation balloon.
    • EditedThe participant hasIt 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 alone.
    • EditedThe non-target lesion must bewas successfully treated at the time of the initial procedure (success measured as ≤30% residual stenosis and no complications).
    • EditedDoesIt does not have stent implantedan endoprosthesis or it 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
    • EditedPregnant, breastfeeding or with intentionintending to become pregnant in the next year.
    • EditedThe participant hasPresents with any planned major endovascular or surgical procedure planned (including in the access circuitloop) within 30 days of the initial procedure.
    • EditedKnown or suspected infection of the hemodialysis access site infection, systemic infection, and/or sepsissepticemia.
    • EditedContraindication to antiplatelet, anticoagulant, or thrombolytic therapies.
    • EditedLife expectancy of less than 12 months.
    • EditedThe participantIt is anticipated that the individual's hemodialysis access is expected towill be abandoned within 6 months.
    • EditedThe participantispatient is enrolledparticipating in another trialresearch study involving an investigational product (pharmaceutical, biologicalbiologic, or medical device).
    • EditedThe patient has a permanent central venous catheter (CVC) for dialysis access, except when itsthe use is temporary, as a bridge to treatment through the access circuit, with and there is a plan for removal after a successful dialysis session after the initial procedure.
    • RemovedThe target lesion is located inside an endoprosthesis
    • RemovedTarget lesion treatment would involve the cannulation segment (needling zone)
    • EditedHas a stent or endoprosthesisstent graft located anywhereat any point in the AV access circuit that is not patent (> 30% stenosis) or implanted < 30 days.
    • EditedIt was not possible to pre-dilateperform predilation of the target lesion to be treated with Solaris DE.
    • EditedThere was a dissection or /rupture of the treated vessel during the initial treatment that could not be controlled.
    • ChangedBefore Evidence of an aneurysm, pseudoaneurysm or acute thrombus (i.e. one that has been treated ≤ 15 days) within the target lesionNow 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).
    • ChangedBefore Through the elbowNow In the elbow region and joint
    • EditedIn a region that causes bending of the endoprosthesisstent graft or bonybone protrusion over it
    • EditedInsideWithin any part of a pre-existing stent or endoprosthesis/stent graft (apart from an accessexcept for the arteriovenous graft of the access)
    • EditedLower extremityEnd
    • EditedCentral thoracic veins located proximalproximally to the arch of the cephalic vein arch.
    • RemovedThe target lesion is located in such a way that the insertion of a stent would result in a "kink" area that requires a stent bridge between the Solaris DE and an existing stent or stent graft
    • EditedThe individualsubject has more than 1one (one1) non-target lesion (≥ 50% stenosis) that requires intervention in the initial procedure.
    Interventions Added Device: Solaris DE (200). Arms added: AVF/ AVG Treatment
    Contact Study contact changed: l•••@scitechmed.com · •••5027→m•••@scitechmed.com · •••3751; a•••@scitechmed.com · •••5027→a•••@scitechmed.com · •••3751. See the current contact
    Title The Solaris DE EndoprosthesisSirolimus-Eluting Covered Stent for the Treatment of AV Access Stenosis or Occlusion
    + 2 other changes: verification date and description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06096142
Lead sponsor
Scitech Produtos Medicos SA
Responsible party
Sponsor
First posted
Oct 23, 2023
Start date
Aug 30, 2024
Primary completion
Oct 1, 2027 (estimated)
Completion
Apr 30, 2029 (estimated)
Last update
Oct 6, 2026

Study contacts

Marco A Costa
Contact
marco.costa@scitechmed.com
+55 62 3625-3751
Ana Paula B A Pellaquim
Contact
aalmeida@scitechmed.com
+55 62 3625-3751
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
Douglas E T Cavalcanti, MD
principal investigator · Real Hospital Português de Beneficência em Pernambuco
Guilherme C Santos, MD
principal investigator · Hospital das Clínicas da UFMG/EBSERH

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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