Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Implanted in Peripheral Vessels
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 280
- 试验地点
- 12
- 主要终点
- Composite of Procedural Success and Freedom From VBX Stent Graft-related Serious Adverse Events
研究概览
简要总结
The primary objective of the VBX 17-04 registry is to collect post-market safety and performance data of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) in peripheral vessels in patients who require interventional treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years.
- •Signed informed consent form
- •Endovascular indication for treatment based on treating physician's best medical judgment.
- •Intend for no other stents to be placed in the same peripheral vessel(s) targeted for VBX Stent Graft placement.
- •Willingness of the patient to adhere to standard of care follow-up requirements.
排除标准
- •Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
- •Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
- •Pregnant or breast-feeding female at time of informed consent signature.
- •Life expectancy < 12 months due to comorbidities.
- •Use of the VBX Stent Graft is for the treatment of de novo iliac occlusive disease.
- •Use of the VBX Stent Graft is for the treatment of aortic coarctations.
- •Use of the VBX Stent Graft in the coronary, pulmonary, carotid, vertebral, isolated infrarenal aortic, or vena cava vessels.
研究组 & 干预措施
GORE VIABAHN VBX Balloon Expandable Endoprosthesis
The GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted according to the institution standard of practice in patients needing preservation of peripheral vessels due to multiple pathologies and conditions.
干预措施: GORE VIABAHN VBX Balloon Expandable Endoprosthesis (Device)
结局指标
主要结局
Composite of Procedural Success and Freedom From VBX Stent Graft-related Serious Adverse Events
时间窗: 30 days post treatment
Number of study subjects experiencing Procedural Success and free from VBX Stent Graft-related Serious Adverse Events within 30 days of index procedure. Procedural Success is defined as: successful access, delivery, accurate deployment, and withdrawal of catheters with patent VBX Stent Graft at end of procedure.
次要结局
未报告次要终点