The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Primary effectiveness as assessed by primary patency
研究概览
简要总结
This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.
详细描述
A maximum of 35 clinical investigative sites in the U.S. will participate in this study. One hundred and fifty subjects are intended to be implanted with the GORE® VIABAHN® FORTEGRA Venous Stent in this study, with a limit of 30 treated subjects per site. Subjects will be evaluated through hospital discharge and return for follow-up visits at 1, 6, 12, 24, and 36 months post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Preoperative Inclusion Criteria:
- •Presence of a lesion necessitating treatment with the GORE® VIABAHN® FORTEGRA Venous Stent, as previously determined by an investigator/sub-investigator.
- •Patient is at least 18 years of age.
- •Patient is willing and able to comply with all follow-up evaluations as well as any required medication or compression regimen.
- •Patient is able to provide informed consent themself.
- •Intraoperative Inclusion Criteria:
- •Patient can accommodate an appropriately sized GORE® VIABAHN® FORTEGRA Venous Stent as per reference vessel diameter (see IFU), as determined by intraoperative IVUS post pre-dilation.
- •Patient must have appropriate access vessels to accommodate the delivery sheath for the selected device size.
- •Patient has adequate landing zones free from significant disease requiring treatment beyond the proximal and distal margins of the lesion.
- •Patient has adequate inflow/outflow to/from the target lesion(s), per investigator/sub- investigator discretion.
- •Lesion can be traversed with a guidewire.
- •Intraoperative
排除标准
- •Patient is contraindicated for treatment with the GORE® VIABAHN® FORTEGRA Venous Stent according to the IFU.
研究组 & 干预措施
GORE® VIABAHN® FORTEGRA Venous Stent
GORE® VIABAHN® FORTEGRA Venous Stent
干预措施: GORE® VIABAHN® FORTEGRA Venous Stent (Device)
结局指标
主要结局
Primary effectiveness as assessed by primary patency
时间窗: 12 months
Rate of subjects with primary patency as confirmed by imaging and adverse events
Primary safety as assessed by SAEs
时间窗: 30 days
Rate of subjects with freedom from device- or index procedure-related SAEs
次要结局
- Rate of subjects with primary patency as confirmed by imaging and adverse events(36 months)
- Rate of subjects with secondary patency as confirmed by imaging and site-reported device abandonment(36 months)
- Rate of subjects with clinically driven target lesion revascularization as confirmed by imaging and adverse events(36 months)
- Number of subjects with stent embolization as confirmed by adverse events and imaging(12 months)
- Number of subjects with device- or index procedure-related death as confirmed with adverse events(30 days)
- Number of subjects with clinically significant pulmonary embolism as confirmed with imaging and adverse events(30 days)
- Number of subjects with device- or index procedure-related vascular injury as confirmed with adverse events(30 days)
- Number of subjects with device- or index procedure-related major bleeding events as confirmed with adverse events(30 days)
- 5 Level EuroQol-5 Dimension (EQ-5D-5L)(36 months)
- Technical success(Index procedure (post-op day 0))
- Lesion success(Index procedure (post-op day 0))