RecruitingNot ApplicableNCT06096142

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

Prospective, Randomized, Controlled, Multicenter Study of the Solaris DE Endoprosthesis in the Treatment of Venous Outflow Stenosis or Occlusion in Hemodialysis Patients

Sponsor

Scitech Produtos Medicos SA

Enrollment

120 participants

Start Date

Aug 30, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Renal Failure Venous Stenosis Venous Occlusion

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria18

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
The participant has 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
Does not have stent implanted or it has been in the access circuit for ≥ 30 days since placement and patent with ≤ 30% stenosis and located ≥ 5 cm from the target lesion
The non-target lesion must be successfully treated at the time of the initial procedure (success measured as ≤30% residual stenosis and no complications).

Exclusion Criteria30

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
The target lesion is located inside an endoprosthesis
Target lesion treatment would involve the cannulation segment (needling zone)
The target lesion is \< 5 cm from the arterial anastomosis
There was a dissection or rupture of the treated vessel during the initial treatment that could not be controlled
Evidence of an aneurysm, pseudoaneurysm or acute thrombus (i.e. one that has been treated ≤ 15 days) within the target lesion
The target lesion is, and/or Solaris DE would be placed anywhere:
Through the elbow
In a region that causes bending of the endoprosthesis or bony protrusion over it
In the cannulation segment (needling zone)
Inside any part of a pre-existing stent or endoprosthesis (apart from an access arteriovenous graft)
Lower extremity
Non-synthetic graft
Central thoracic veins located proximal to the cephalic vein arch
The 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
The individual has more than 1 (one) non-target lesion (≥ 50% stenosis) that requires intervention in the initial procedure