Safety and Efficacy of Thrombolysis in Combination With Endhole Aspiration in the Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Post-thrombotic Syndrome (PTS) severity using the Villalta score
研究概览
简要总结
The purpose of this study is to demonstrate the safety and efficacy of thrombolysis in combination with endhole aspiration in the treatment of acute deep vein thrombosis (DVT). Secondarily, the study team hope to illuminate the financial implications of single session catheter directed therapy versus a potential 48 hour lysis procedure (Lysis is an approach in which vascular specialists deliver clot-dissolving drugs directly to the site of the clot through a catheter).
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
- •Over 18 years of age
- •Onset of acute DVT occurred <14 days
- •Ability to undergo thrombolysis in combination with Indigo endhole aspiration device
排除标准
- •Under 18 years of age
- •Presence of subacute (14-28 days) or chronic DVT (>28 days)
- •Contraindication to mechanical thrombectomy
结局指标
主要结局
Post-thrombotic Syndrome (PTS) severity using the Villalta score
时间窗: 1 month
Patient outcomes will be measured through clinical grading of PTS severity using the Villalta score, a clinical measure for the post-thrombotic syndrome that grades the severity, from 0 (absent) to 3 (severe), of each of 5 patient-rated symptoms (pain, cramps, heaviness, pruritus, and paresthesia) and 6 clinician-rated clinical signs (edema, redness, skin induration, hyperpigmentation, venous ectasia, and pain of calf). A summative score of 5 or more on the Villalta scale indicates the presence of the postthrombotic syndrome (Villalta).
次要结局
未报告次要终点