慢性 DVT 的 2/2 导管定向治疗（C-TRACT 试验）-DCC-猫眼课题宝

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

项目类别：

财政年份：

2017

资助国家：

美国

项目状态：

已结题

起止时间：

2017-09-01 至 2023-08-31

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

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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.

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