1/2 CATHETER-DIRECTED THERAPY FOR CHRONIC DVT (C-TRACT TRIAL)

慢性 DVT 的 1/2 导管导向治疗（C-TRACT 试验）

• 批准号: 9998750
• 负责人: SURESH VEDANTHAM
• 金额: $ 168.84万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9998750
• 关键词: Ablation; Acute; Anatomy; Award; Blinded; Blood flow; Caring; Catheters; Chronic; Chronic Care; Chronic Phase; Clinical; Clinical Trials; Complication; Custodial Care; Deep Vein Thrombosis; Disease; Edema; Effectiveness; Excision; Grant; Health; Health Care Costs; Hemorrhage; Iliac Vein; Image; Impairment; Intervention; Leg Ulcer; Life; Lower Extremity; Measures; Medical; Medical Care Costs; Mission; Modeling; National Heart, Lung, and Blood Institute; Observational Study; Obstruction; Odds Ratio; Outcome Study; Pain; Pain in lower limb; Participant; Patients; Physiological; Postphlebitic Syndrome; Prediction of Response to Therapy; Process; Productivity; Public Health; Quality of life; Quality-Adjusted Life Years; Randomized Controlled Trials; Recurrence; Reflux; Research; Resource Development; Risk; SF-36; Safety; Secondary to; Severities; Societies; Standardization; Stasis dermatitis; Stents; Swelling; Testing; Therapy trial; Thrombosis; Thrombus; Ulcer; Varicose Ulcer; Veins; Venous; Venous Thrombosis; Work; arm; base; care costs; claudication; clinical practice; cost; cost effective treatment; cost effectiveness; cost estimate; daily functioning; disability; economic evaluation; effectiveness evaluation; evidence base; experience; follow-up; healing; health economics; health related quality of life; image guided; improved; incremental cost-effectiveness; open label; prevent; primary outcome; randomized trial; secondary outcome; skin ulcer; thrombolysis; treatment strategy

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.

项目摘要 血栓后综合征（PTS）是下肢深静脉血栓形成的永久性并发症 （DVT）。继发于慢性髂静脉阻塞的中重度PTS患者的经验 疼痛、大量水肿、淤滞性皮炎和/或静脉性皮炎导致严重残疾和生活质量受损 腿部溃疡（“致残性髂动脉阻塞性PTS”[DIO-PTS]）。目前，没有循证治疗， DIO-PTS。观察性研究和一项小型单中心随机试验表明， 基于导管的血管内治疗（EVT），消除髂静脉阻塞（支架置入）， 隐静脉瓣膜反流（静脉内消融）是有效的。然而，EVT具有风险且成本高。 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（ 慢性静脉血栓形成：辅助导管引导治疗缓解（C-TRACT）研究 将在374例DIO-PTS患者中比较EVT与无EVT。所有患者将接受最佳 PTS的标准化药物治疗。主要结局为受试者内PTS改善 使用静脉临床严重程度评分（VCSS）盲法评估6个月内的严重程度。二次 结局包括PTS严重程度（VCSS、Villalta、溃疡愈合）和静脉疾病特异性（VEINES-QOL） 以及6个月和24个月时的一般（SF-36）生活质量。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个月时进行评估，并进行静脉成像， 确定治疗反应解剖学和生理学预测因子。C-TRACT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的标准治疗的一部分;如果不是， 将避免危险和昂贵的治疗。因此，任何一项研究结果都将改善公众健康， 推进NHLBI的使命。