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

慢性 DVT 的 2/2 导管定向治疗（C-TRACT 试验）-DCC

• 批准号: 9369792
• 负责人: Clive Kearon
• 金额: $ 34.05万
• 依托单位: MCMASTER 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9369792
• 关键词: Ablation; Adverse event; Anatomy; Biometry; Blinded; Blood flow; Budgets; Catheters; Cessation of life; Chronic; Clinical; Clinical Trials; Clinical Trials Data Monitoring Committees; Complication; Cost Effectiveness Analysis; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Set; Databases; Deep Vein Thrombosis; Disease; Economics; Edema; Enrollment; Ensure; Event; Frequencies; Generic Drugs; Goals; Health Care Costs; Hemorrhage; Iliac Vein; Image; Impairment; Leg Ulcer; Lower Extremity; Measurement; Medical; Methodology; Minor; Mission; Modeling; Monitor; National Heart, Lung, and Blood Institute; Observational Study; Obstruction; Outcome; Outcome Study; Pain; Pain in lower limb; Patients; Physiological; Postphlebitic Syndrome; Process; Productivity; Protocols documentation; Public Health; Publications; Quality of life; Randomized; Randomized Controlled Trials; Recurrence; Reflux; Reporting; Risk; SF-36; Safety; Secondary to; Secure; Severities; Skin Ulcer; Societies; Standardization; Stasis dermatitis; Statistical Data Interpretation; Stents; Swelling; Therapy trial; Thromboembolism; Thrombosis; Time; Ulcer; Ultrasonography; Venous; Venous Thrombosis; Work; Writing; adjudication; base; clinical practice; cost; cost effective; data integrity; design; disability; effective therapy; evidence base; experience; follow-up; healing; health economics; image guided; improved; incremental cost-effectiveness; open label; primary outcome; randomized trial; screening; secondary outcome; treatment response; trial design

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.

项目总结