Clinical Trial TitleChronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial) (C-TRACT)
National Clinical Trial Number:NCT03250247
Clinical Trial Protocol Description:
In patients with established disabling iliac-obstructive post-thrombotic syndrome (DIO-PTS) who are receiving standard post-thrombotic syndrome (PTS) care, to determine if the use of endovascular therapy (EVT) provides greater improvement in PTS severity and health-related quality of life compared with no EVT (No-EVT) over 6 months follow-up. The purpose of this research study is to determine which of these two PTS treatment approaches provides patients with greater improvement in their PT) symptoms and in their quality of life.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have disabling (moderate-to-severe) PTS, defined by a) presence of chronic venous disease > 3 months duration in a leg with a history of DVT, as determined by the site principal investigator or a physician co-investigator; and b) substantial limitation of daily activities or work capacity due to venous symptoms or an open venous ulcer, per the same investigator.
- Have ipsilateral iliac vein obstruction, documented within 12 months prior to consent by either:
- Occlusion or > 50% stenosis of the iliac vein on venogram, CT venogram, MR venogram, or intravascular ultrasound (IVUS); or
- Air plethysmography showing deep venous obstruction of the ipsilateral leg (reduced venous outflow fraction), and ultrasound showing echogenic material in the ipsilateral iliac vein and non-phasic continuous Doppler flow in the ipsilateral common femoral vein (CFV) in the presence of normal phasic Doppler flow in the contralateral CFV.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.