2/2 Catheter-Directed Therapy for Chronic DVT (C-TRACT Trial)-DCC

项目总结 血栓后综合征(PTS)是下肢深静脉的永久性并发症 血栓形成(DVT)。慢性髂静脉阻塞继发中重度PTS患者 因疼痛、大量浮肿、淤积性皮炎而严重致残和生活质量受损， 和/或静脉性腿部溃疡(“禁用髂动脉阻塞性PTS”[DIO-PTS])。目前，没有证据表明- DIO-PTS的基础治疗。观察性研究和一项小型单中心随机试验表明 影像引导、基于导管的血管内治疗(EVT)消除髂静脉阻塞(支架 放置)和隐静脉瓣膜返流(静脉内消融)是有效的。然而，EVT拥有 风险和成本都很高。 因此，我们计划进行一项开放标签、评估者盲法、多中心、随机对照试验(The 慢性静脉血栓形成：辅助导管导向治疗(C-TRADE)研究 这将比较374名DIO-PTS患者的EVT和非EVT。所有患者都将得到最佳 规范的PTS内科治疗。主要结果将是受试者在PTS中的改善 严重程度超过6个月，使用静脉临床严重程度评分(VCS)盲法评估。次要的 结果包括PTS的严重程度(VCS、Villalta、溃疡愈合)和特定于静脉疾病的(静脉- 生活质量(QOL)和一般生活质量(SF-36)。全面的卫生经济分析 将比较医疗成本并估计EVT的增量成本效益。安全性(例如，出血、 复发性血栓形成)将在2、6和24个月进行评估，并将进行静脉成像以 确定治疗反应的解剖学和生理学预测因子。C-Track研究将发生变化 临床实践：如果EVT是有效和安全的，它将成为DIO-PTS标准治疗的一部分；如果不是，一个 将避免高风险和昂贵的治疗。因此，无论哪一项研究结果都将改善公众健康和 推进NHLBI的任务。

PROJECT SUMMARY The post-thrombotic syndrome (PTS) is a permanent complication of lower extremity deep vein thrombosis (DVT). Patients with moderate-to-severe PTS secondary to chronic iliac vein obstruction experience profound disability and quality of life impairment from pain, massive edema, stasis dermatitis, and/or venous leg ulcers ("Disabling Iliac-Obstructive PTS” [DIO-PTS]). Currently, there is no evidence- based therapy for DIO-PTS. Observational studies and a small single-center randomized trial suggest that imaging-guided, catheter-based endovascular therapy (EVT) that eliminates iliac vein obstruction (stent placement) and saphenous venous valvular reflux (endovenous ablation) is effective. However, EVT has risks and is costly. We therefore plan to do an open-label, assessor-blinded, multicenter, randomized controlled trial (the Chronic Venous Thrombosis: Relief with Adjunctive Catheter-Directed Therapy (C-TRACT) Study) that will compare EVT with No-EVT in 374 patients with DIO-PTS. All patients will receive optimal standardized medical therapy for PTS. The primary outcome will be within-subject improvement in PTS severity over 6 months, assessed blindly using the Venous Clinical Severity Score (VCSS). Secondary outcomes include PTS severity (VCSS, Villalta, ulcer healing), and venous disease-specific (VEINES- QOL) and generic (SF-36) quality of life at 6 and 24 months. A comprehensive health economic analysis will compare medical costs and estimate the incremental cost-effectiveness of EVT. Safety (e.g. bleeding, recurrent thrombosis) will be assessed at 2, 6, and 24 months, and venous imaging will be performed to identify anatomic and physiologic predictors of therapeutic response. The C-TRACT Study will change clinical practice: if EVT is effective and safe, it will become part of standard therapy for DIO-PTS; if not, a risky and costly therapy will be avoided. Hence, either study outcome will improve public health and advance the NHLBI’s mission.