Retrospective Post-Market Clinical Follow-Up Study of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft in Peripheral Artery Disease, Aortic Aneurysms, and Dialysis Access
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 356
- 试验地点
- 8
- 主要终点
- PAD Cohort: Primary Safety Outcome: Device-related Seroma or Infection
研究概览
简要总结
This multicenter, single-arm retrospective registry (chart review) is being conducted to confirm the clinical performance and safety of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft throughout the device functional lifetime for each indication area.
详细描述
Up to 9 sites in Europe will be required to enroll 353 patients that have had treatment with GORE-TEX® Vascular Grafts or GORE® PROPATEN® Vascular Grafts in the following indication areas:
144 patients in PAD Cohort
- 72 Patients with any GORE-TEX® Vascular Graft
- 72 Patients with GORE® PROPATEN® 65 patients in Aortic Aneurysm Cohort with GORE-TEX® Vascular Graft 144 patients in Dialysis Access Cohort
- 72 patients implanted with any GORE-TEX® Vascular Graft
- 72 Patients implanted with Patients with GORE® PROPATEN®
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria
- •Patient is willing and able to provide written informed consent or consent is waived, according to national and local regulations.
- •Patient was at least 18 years of age at the time of implant.
- •PAD Cohort Inclusion Criteria
- •Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft at least 5 years before site initiation.
- •Aortic Aneurysm Cohort Inclusion Criteria
- •Patient underwent simultaneous or staged aortic aneurysm repair (open surgical AAA or TAAA) involving a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft at least 5 years before site initiation. Research device could have been used to replace or bypass either a diseased visceral branch or the aorta itself.
- •Dialysis Access Cohort Inclusion Criteria
- •Patient required the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease using a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft at least 2 years before site initiation with the intent to cannulate the registry device.
排除标准
- •General Exclusion Criteria
- •Patient was not available for follow up (on-site or remotely) at the clinical site, with the exception of death (e.g., patient lost to follow-up immediately after treatment, patients who live far away from the clinical site and are not available to share follow-up data performed locally).
- •At the time of treatment, patient had known coagulation disorders, including hypercoagulability, that were not amenable to treatment.
- •Patient was pregnant at the time of treatment.
- •Patient had known or suspected systemic infection or infection at the site of graft implantation at the time of implant.
- •Patient had a separate major interventional or surgical vascular procedure within 30 days prior to treatment. CVC catheter placement would be permitted.
- •Patient is already enrolled in this registry under a different cohort.
- •PAD Cohort Exclusion Criteria
- •At the time of treatment, the patient must not have met any of the following criteria:
- •Patient had percutaneous transluminal angioplasty (PTA) or stenting of the target artery at the anticipated site of the proximal or distal anastomosis within 30 days prior to the index procedure. Use of PTA or stenting during the index procedure is permitted.
- •Patient had a stroke or myocardial infarction (MI) within 6 weeks prior to the index procedure.
- •Patient has previous instance of Heparin-induced Thrombocytopenia type 2 or has known hypersensitivity to heparin.
- •Patient required composite bypass for index procedure (graft + significant length of autologous vessel). Autologous "cuffs" or patches are allowed.
- •Aortic Aneurysm Cohort Exclusion Criteria
- •At the time of treatment, the patient must not have met any of the following criteria:
- •Patient required emergency surgery due to aneurysm rupture.
- •Dialysis Access Cohort Exclusion Criteria
- •At the time of treatment, the patient must not have met any of the following criteria:
- •The patient had a previous documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.
- •The patient was taking maintenance immunosuppressant medication at the time of implant such as rapamycin, mycophenolate or mycophenolic acid, prednisone (> 10 mg), cyclosporine, tacrolimus, or cyclophosphamide.
- •The patient has had a previous instance of Heparin-Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin.
结局指标
主要结局
PAD Cohort: Primary Safety Outcome: Device-related Seroma or Infection
时间窗: Data were collected retrospectively from health registries, for up to 5 years after index procedure date
Clinical evidence of an infectious process in the direct vicinity of the access site or distal to the treated vascular site or seroma classified by the registry investigator as primarily related to the registry device.
PAD Cohort: Primary Performance Outcome: Secondary Patency (Revascularization)
时间窗: Data were collected retrospectively from health registries, for up to 5 years after index procedure date
Patency of the study graft with additional or secondary surgical or endovascular procedures to restore flow to the graft after occlusion or stenosis of the graft or its anastomoses. The only exceptions that do not disqualify the graft for secondary patency are procedures performed for disease beyond the graft and its two anastomoses.
Aortic Aneurysm Cohort: Primary Safety Outcome: Survival Through 5 Years
时间窗: Data were collected retrospectively from health registries, for up to 5 years after index procedure date
All Cause survival
Aortic Aneurysm Cohort: Primary Performance Outcome: Primary Patency Through 5 Years
时间窗: Data were collected retrospectively from health registries, for up to 5 years after index procedure date
Patency of the study graft without additional or secondary surgical or endovascular procedures to maintain or restore flow to the graft. The only exceptions that do not disqualify the graft for primary patency are procedures performed for disease beyond the graft and its two anastomoses.
Dialysis Access Cohort: Primary Safety Outcome: Device-related Infection Through 2 Years
时间窗: Data were collected retrospectively from health registries, for up to 2 years after index procedure date
Clinical evidence of an infectious process in the direct vicinity of the access site classified by the study investigator as primarily related to the study device.
Dialysis Access Cohort: Useable Access Circuit (Reported as Secondary Patency) Through 2 Years
时间窗: Data were collected retrospectively from health registries, for up to 2 years after index procedure date
Patency of the study graft from the time of access creation or placement until access abandonment.
次要结局
- Peripheral Artery Disease Cohort: Limb Salvage Through 1 Year(Data were collected retrospectively from health registries, for up to 1 year after index procedure date)
- Peripheral Artery Disease Cohort: Amputation-free Survival Through 1 Year(Data were collected retrospectively from health registries, for up to 1 year after index procedure date)
- Peripheral Artery Disease Cohort: Device-related Adverse Events Through 1 Year(Data were collected retrospectively from health registries, for up to 1 year after index procedure date)
- Peripheral Artery Disease Cohort: Primary Patency Through 1 Year(Data were collected retrospectively from health registries, for up to 1 year after index procedure date)
- Peripheral Artery Disease Cohort: Device-related Infection Requiring Reoperation Through 5 Years(Data were collected retrospectively from health registries, for up to 5 years after index procedure date)
- Dialysis Access Cohort: Primary Patency Through 1 Year(Data were collected retrospectively from health registries, for up to 1 year after index procedure date)
- Dialysis Access Cohort: Device-related Adverse Events Through 1 Year(Data were collected retrospectively from health registries, for up to 1 year after index procedure date)