Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 主要终点
- Primary Entry Tear Exclusion
研究概览
简要总结
Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Primary Entry Tear Exclusion
时间窗: At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)
Number of subjects who achieved the primary entry tear exclusion
Aortic Rupture
时间窗: Procedure through 5 years (Day 0-2006)
Number of subjects with Aortic Rupture
Major Device-related Adverse Events
时间窗: Procedure through 5 years (Day 0-2006)
Number of subjects with major device-related adverse events
Secondary Intervention Treatment
时间窗: Post-procedure through 5 years (Day 1-2006)
Incidence rate of secondary intervention treatment
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
时间窗: At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)
Change in minimum true lumen diameter adjacent to treated segment at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)
Change in Minimum True Lumen Diameter Distal to Treated Segment
时间窗: At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)
Change in minimum true lumen diameter distal to treated segment at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
时间窗: At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)
Change in maximum false lumen diameter adjacent to treated segment at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)
Change in Maximum False Lumen Diameter Distal to Treated Segment
时间窗: At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)
Change in maximum false lumen diameter distal to treated segment at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)
Change in Maximum Lesion Diameter
时间窗: At each follow-up visit from 6 months through 5 years: 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)
Change in maximum lesion diameter at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)
次要结局
未报告次要终点