The Solaris DE Sirolimus-Eluting Covered Stent for the Treatment of AV Access Stenosis or Occlusion (DEScover)
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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).
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Marco A Costa
- 전화번호: +55 62 3625-3751
- 이메일: marco.costa@scitechmed.com
연구 연락처 백업
- 이름: Ana Paula B A Pellaquim
- 전화번호: +55 62 3625-3751
- 이메일: aalmeida@scitechmed.com
연구 장소
-
-
Estado de Bahia
-
Salvador, Estado de Bahia, 브라질, 40323-010
- 모병
- Hospital Ana Nery
-
수석 연구원:
- Leonardo Cortizo, MD
-
연락하다:
- Leonardo Cortizo, MD
-
-
Federal District
-
Brasília, Federal District, 브라질, 70390-150
- 모병
- Afya Hospital Dia LTDA
-
수석 연구원:
- Thiago Barroso, MD
-
연락하다:
- Thiago A Barroso, MD
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, 브라질, 30130-100
- 모병
- Hospital das Clínicas da UFMG/EBSERH
-
연락하다:
- Guilherme Castro, MD
-
수석 연구원:
- Guilherme Castro, MD
-
-
Pernambuco
-
Recife, Pernambuco, 브라질, 52010-160
- 모병
- Real Hospital Português de Beneficência em Pernambuco
-
수석 연구원:
- Douglas Cavalcanti, MD
-
연락하다:
- Douglas Cavacanti, MD
-
-
Rio de Janeiro
-
Rio de Janeiro, Rio de Janeiro, 브라질, 20551030
- 모병
- Hospital Universitário Pedro Ernesto - UERJ
-
연락하다:
- Leonardo O Harduin, MD
-
수석 연구원:
- Leonardo O Harduin, MD
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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:
-
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.
Exclusion Criteria:
- 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.
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: AVF Treatment
Participants on dialysis via AV fistula will be treated with percutaneous transluminal angioplasty (PTA) followed by Solaris DE implantation. |
Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (75μg of Sirolimus) implantation in the treated vessel. |
|
가짜 비교기: AVF Control
Participants on dialysis via AV fistula will be treated with percutaneous transluminal angioplasty (PTA) alone. |
Percutaneous Transluminal Angioplasty (PTA) in the treated vessel alone. |
|
실험적: AVG Treatment
Participants on dialysis via AV graft will be treated with percutaneous transluminal angioplasty (PTA) followed by Solaris DE implantation. |
Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (75μg of Sirolimus) implantation in the treated vessel. |
|
실험적: 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. |
Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (200μg of Sirolimus) implantation in the treated vessel. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Safety Events
기간: 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)
기간: 6 months
|
Percentage of participants without restenosis or clinically indicated target lesion revascularization or thrombosis. |
6 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Target Lesion Primary Patency (TLPP)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 1, 6, 12 and 24 months
|
Complication rates related to the procedure and device involving the access circuit. |
1, 6, 12 and 24 months
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Leonardo C Almeida, MD, Hospital Ana Nery
- 수석 연구원: Thiago A Almeida, MD, Afya Hospital Dia LTDA
- 수석 연구원: Douglas E T Cavalcanti, MD, Real Hospital Português de Beneficência em Pernambuco
- 수석 연구원: Guilherme C Santos, MD, Hospital das Clínicas da UFMG/EBSERH
- 수석 연구원: Leonardo O Harduin, PhD, Hospital Universitário Pedro Ernesto - Universidade do Estado do Rio de Janeiro (HUPE-UERJ)
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- SCI-SD-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .