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

2026年10月1日 更新者：Scitech Produtos Medicos SA

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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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).

研究の種類

介入

入学 (推定)

160

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • ブラジル
    • Estado de Bahia
      • Salvador、Estado de Bahia、ブラジル、40323-010
        • 募集
        • Hospital Ana Nery
        • 主任研究者：
          • Leonardo Cortizo, MD
        • コンタクト：
          • Leonardo Cortizo, MD
    • Federal District
      • Brasília、Federal District、ブラジル、70390-150
        • 募集
        • Afya Hospital Dia LTDA
        • 主任研究者：
          • Thiago Barroso, MD
        • コンタクト：
          • Thiago A Barroso, MD
    • Minas Gerais
      • Belo Horizonte、Minas Gerais、ブラジル、30130-100
        • 募集
        • Hospital das Clínicas da UFMG/EBSERH
        • コンタクト：
          • Guilherme Castro, MD
        • 主任研究者：
          • Guilherme Castro, MD
    • Pernambuco
      • Recife、Pernambuco、ブラジル、52010-160
        • 募集
        • Real Hospital Português de Beneficência em Pernambuco
        • 主任研究者：
          • Douglas Cavalcanti, MD
        • コンタクト：
          • Douglas Cavacanti, MD
    • Rio de Janeiro
      • Rio de Janeiro、Rio de Janeiro、ブラジル、20551030
        • 募集
        • Hospital Universitário Pedro Ernesto - UERJ
        • コンタクト：
          • Leonardo O Harduin, MD
        • 主任研究者：
          • Leonardo O Harduin, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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 informed consent 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:

  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 immunosuppressive therapy.
  6. Known active coagulopathy or bleeding diathesis.
  7. Known hypersensitivity to nickel titanium alloy, contrast or Sirolimus.
  8. Contraindication 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. Life expectancy 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 investigational 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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：AVF Treatment

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

Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (75μg of Sirolimus) implantation in the treated vessel.
偽コンパレータ：AVF Control

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

Percutaneous Transluminal Angioplasty (PTA) in the treated vessel alone.
実験的：AVG Treatment

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

Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (75μg of Sirolimus) implantation in the treated vessel.
実験的：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.
デバイス：Solaris DE (200)

Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (200μg of Sirolimus) implantation in the treated vessel.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Safety Events
時間枠：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).
30 days
Target Lesion Primary Patency (TLPP)
時間枠：6 months

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

二次結果の測定

結果測定
メジャーの説明
時間枠
Target Lesion Primary Patency (TLPP)
時間枠：12 and 24 months

Percentage of participants without restenosis or clinically indicated target lesion revascularization or thrombosis.
12 and 24 months
Assisted Target Lesion Primary Patency (aTLPP)
時間枠：1, 6, 12 and 24 months

Percentage of participants without uncorrectable occlusion of the target lesion since the procedure.
1, 6, 12 and 24 months
Access Circuit Primary Patency (ACPP)
時間枠：1, 6, 12 and 24 months

Percentage of participants without any new venous outflow circuit intervention, thrombosis or access abandonment since the procedure.
1, 6, 12 and 24 months
Cumulative Patency (CP)
時間枠：1, 6, 12 and 24 months

Percentage of participants without the access circuit abandonment since the procedure.
1, 6, 12 and 24 months
Procedure and device-related complications
時間枠：1, 6, 12 and 24 months

Complication rates related to the procedure and device involving the access circuit.
1, 6, 12 and 24 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Scitech Produtos Medicos SA

捜査官

  • 主任研究者：Leonardo C Almeida, MD、Hospital Ana Nery
  • 主任研究者：Thiago A Almeida, MD、Afya Hospital Dia LTDA
  • 主任研究者：Douglas E T Cavalcanti, MD、Real Hospital Português de Beneficência em Pernambuco
  • 主任研究者：Guilherme C Santos, MD、Hospital das Clínicas da UFMG/EBSERH
  • 主任研究者：Leonardo O Harduin, PhD、Hospital Universitário Pedro Ernesto - Universidade do Estado do Rio de Janeiro (HUPE-UERJ)

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年8月30日

一次修了 (推定)

2027年10月1日

研究の完了 (推定)

2029年4月30日

試験登録日

最初に提出

2023年10月17日

QC基準を満たした最初の提出物

2023年10月17日

最初の投稿 (実際)

2023年10月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月6日

QC基準を満たした最後の更新が送信されました

2026年10月1日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • SCI-SD-001

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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いいえ

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いいえ

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