A Clinical Trial of Venous Stent Placement for Post-thrombotic Syndrome: Current Status and Pandemic-related Changes.
Suresh VedanthamSameer ParpiaSusan R KahnPublished in: Vascular and endovascular review (2022)
Patients with post-thrombotic syndrome (PTS) and iliac vein obstruction have lower extremity symptoms, activity limitation and impairment of health-related quality of life. Preliminary studies suggest that iliac vein stent placement, which eliminates venous outflow obstruction, may reduce the clinical severity of PTS. However, stent placement is associated with patient risk, inconvenience and cost. Therefore, the Chronic Venous Thrombosis - Relief with Adjunctive Catheter-directed Therapy (C-TRACT) trial was launched to rigorously assess the risk-benefit ratio of stent placement for the treatment of moderate or severe PTS. In the trial, patients in both treatment groups receive a high quality of multimodality PTS care that includes medical, compressive, and ulcer therapies. Due to the COVID-19 pandemic, the trial protocol and practices were modified to enhance the study feasibility while preserving its ability to answer its primary question. This review summarises the current status of the trial and the potential impact of the pandemic-related adaptations to future venous clinical practice and research.
Keyphrases
- current status
- clinical trial
- phase iii
- study protocol
- phase ii
- ultrasound guided
- healthcare
- sars cov
- end stage renal disease
- coronavirus disease
- case report
- randomized controlled trial
- clinical practice
- open label
- high intensity
- ejection fraction
- chronic kidney disease
- palliative care
- double blind
- patient reported outcomes
- peritoneal dialysis
- mesenchymal stem cells
- risk assessment
- pain management
- placebo controlled
- physical activity