The Solaris DE Endoprosthesis for the Treatment of AV Access Stenosis or Occlusion

NCT06096142 | Recruiting DMC

• 1 other identifier: SCI-SD-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Chronic Renal Failure; Venous Stenosis; Venous Occlusion

Outcome Measures

Primary Outcomes (2)

• 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).

  30 days

• Target Lesion Primary Patency (TLPP)

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

  6 months

Secondary Outcomes (5)

• Target Lesion Primary Patency (TLPP)

  12 and 24 months

• Assisted Target Lesion Primary Patency (aTLPP)

  1, 6, 12 and 24 months

• Access Circuit Primary Patency (ACPP)

  1, 6, 12 and 24 months

• Cumulative Patency (CP)

  1, 6, 12 and 24 months

• Procedure and device-related complications

  1, 6, 12 and 24 months

Study Arms (3)

AVF Treatment

EXPERIMENTAL

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

Device: Solaris DE

AVF Control

SHAM COMPARATOR

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

Device: PTA

AVG Treatment

EXPERIMENTAL

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

Device: Solaris DE

Interventions

Solaris DE DEVICE

Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE implantation in the treated vessel.

AVF Treatment; AVG Treatment

PTA DEVICE

Percutaneous Transluminal Angioplasty (PTA) in the treated vessel alone.

AVF Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• The target lesion originates ≥ 3 cm from the cannulation segment (needling zone)
• The target lesion is located:
• In one arm (including the cephalic arch) in a participant with AVF, and not in the cannulation segment, OR
• In the anastomosis or juxta-anastomosis in a participant with AVF (a juxta-anastomosis is defined as a location where the stent crosses the venous anastomosis)
• The target lesion includes a de novo stenotic lesion or restenosis
• The target lesion is ≥ 5 cm from the arterial anastomosis
• The target lesion has ≥ 50% stenosis according to the operator's visual judgment
• The distal reference vessel diameter of the target lesion is between 4.0 mm and 9.0 mm by the operator's visual judgment
• Single or multiple target lesions measuring ≤ 8 cm in total length by the operator's visual judgment
• Single or multiple target lesions should be covered by a single stent or multiple overlapping stents, provided they are treated as a single lesion with a maximum length of 8 cm
• Successful target lesion pre-dilatation is defined as crossover of the guidewir resulting in full expansion of the pre-dilatation balloon

You may not qualify if:

• 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
• Known or suspected infection of the hemodialysis access site, systemic infection and/or sepsis
• Patients on immunosuppressive therapy
• Known active coagulopathy or bleeding diathesis
• 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 of less than 12 months
• Has a stent or endoprosthesis located anywhere in the AV access circuit that is not patent (\> 30% stenosis) or implanted \< 30 days
• The participant's hemodialysis access is expected to be abandoned within 6 months
• The participantis is enrolled in another trial involving an investigational product (pharmaceutical, biological or medical device)
• The patient has a permanent central venous catheter (CVC) for dialysis access, except when its use is temporary, as a bridge to treatment through the access circuit, with a plan for removal after a successful dialysis session after the initial procedure

Sponsors & Collaborators

• Scitech Produtos Medicos SA: lead

Study Sites (5)

Hospital Ana Nery

Salvador, Estado de Bahia, 40323-010, Brazil

RECRUITING

Afya Hospital Dia LTDA

Brasília, Federal District, 70390-150, Brazil

RECRUITING

Hospital das Clínicas da UFMG/EBSERH

Belo Horizonte, Minas Gerais, 30130-100, Brazil

RECRUITING

Real Hospital Português de Beneficência em Pernambuco

Recife, Pernambuco, 52010-160, Brazil

RECRUITING

Hospital Universitário Pedro Ernesto - UERJ

Rio de Janeiro, Rio de Janeiro, 20551030, Brazil

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Leonardo O Harduin, MD

  Hospital Universitário Pedro Ernesto - Universidade do Estado do Rio de Janeiro (HUPE-UERJ)

  PRINCIPAL INVESTIGATOR

• Leonardo C Almeida, MD

  Hospital Ana Nery

  PRINCIPAL INVESTIGATOR

• Thiago A Almeida, MD

  Afya Hospital Dia LTDA

  PRINCIPAL INVESTIGATOR

• Douglas E T Cavalcanti, MD

  Real Hospital Português de Beneficência em Pernambuco

  PRINCIPAL INVESTIGATOR

• Guilherme C Santos, MD

  Hospital das Clínicas da UFMG/EBSERH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciano A Curado

CONTACT

+55 62 3625-5027; lcurado@scitechmed.com

Ana Paula B Almeida, MSc.

CONTACT

+55 62 3625-5027; aalmeida@scitechmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: August 30, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (5)