CHRONIC VENOUS THROMBOSIS: RELIEF WITH ADJUNCTIVE CATHETER-BASED THERAPY (C-TRACT

描述(申请人提供)：严重的髂动脉梗阻性血栓后综合征(SIO-PTS)是一种罕见的下肢深静脉血栓形成(DVT)并发症，患者经历严重的残疾和生活质量(QOL)损害。由于缺乏对SIO-PTS的循证治疗，受影响的患者往往被忽视或被不合理的当地意见管理。我们的长期目标有两个：1)验证可以减少PTS症状的有效治疗方法，并使我们不幸的SIO-PTS患者获得更好的健康、肢体功能和生活质量；2)在我们为NHLBI赞助的正在进行的急性DVT导管治疗试验(CATIE试验)开发的临床试验基础设施内，扩大专业知识的范围，以便能够应对慢性DVT和PTS治疗方面的挑战。我们目前申请U34临床试验计划资助的主要目标是完善和最终确定启动慢性静脉血栓形成：基于导管的辅助治疗缓解(C-TRAIL)研究所需的临床研究方案和试验能力的开发，这是一项多中心随机对照试验，将严格确定影像引导血管内治疗的创新策略对已确定的SIO-PTS患者的益处是否大于风险和成本。通过将勤奋的计划、专业知识与先进的方法学和生物统计学试验设计相结合(由U24血液疾病临床试验发展资源提供)，以及系统地努力吸引社区合作伙伴，我们预计将创造A)出色的临床试验方案；B)快速登记和完成拟议研究的潜力；以及C) 多学科研究小组，最终在推动最佳临床实践和未来研究以满足慢性DVT和PTS患者需求方面发挥区域领导作用。

DESCRIPTION (provided by applicant): Patients with severe iliac-obstructive post-thrombotic syndrome (SIO-PTS), a rare complication of lower extremity deep vein thrombosis (DVT), experience profound disability and quality of life (QOL) impairment. Because there is a lack of evidence-based therapy for SIO- PTS, affected patients tend to have their condition either neglected or managed by poorly- justified local opinion. Our long-term goals are two-fold: 1) to validate effective therapy that can reduce PTS symptoms and restore our unfortunate patients with SIO-PTS to better health, limb function, and QOL; and 2) to extend the range of expertise within the clinical trial infrastructure we developed for an ongoing NHLBI-sponsored trial of catheter-based therapy for acute DVT (the ATTRACT Trial) to be able to address challenges in the treatment of chronic DVT and PTS. Our main objective of the current application for a U34 Clinical Trial Planning Grant is to refine and finalize the development of the clinical research protocol and trial capability that are needed to launch the Chronic Venous Thrombosis: Relief with Adjunctive Catheter-Based Therapy (C-TRACT) Study, a multicenter randomized controlled trial that will rigorously determine if the benefits of an innovative strategy of imaging-guided endovascular treatment for patients with established SIO-PTS outweigh the risks and costs. By combining diligent planning, expertise with advanced methodological and biostatistical trial designs (provided by the U24 Clinical Trials Development Resource for Hematologic Disorders), and systematic efforts to engage community partners, we expect to create A) an outstanding clinical trial protocol; B) the potential to rapidly enroll and complete the proposed study; and C) multidisciplinary research groups that can ultimately serve as regional leaders in driving best clinical practices and future research studies to address the needs of patients with chronic DVT and PTS.