Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)

Eligibility Criteria

• 1. Disabling (moderate-to-severe) PTS, defined by a) presence of chronic venous disease \> or = 3 months duration in a leg with 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.
• 2. Ipsilateral iliac vein obstruction documented within 12 months prior to screening by either:
• 1. Occlusion or \>50% or = 50% stenosis of the iliac vein on venogram, CT venogram, MR venogram, or intravascular ultrasound (IVUS) or
• 2. 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.
• 1. Age less than 18 years
• 2. Acute ipsilateral proximal DVT episode within the last 3 months, or acute contralateral DVT for which thrombolytic therapy is planned
• 3. Lack of suitable inflow into the ipsilateral common femoral vein per the treating physician
• 4. Previous stent placement in the infrarenal IVC or ipsilateral iliac or common femoral vein
• 5. Absence of PTS of at least moderate severity
• 6. Chronic arterial limb ischemia (ankle-brachial index \< 0.5 within the previous 1 month) in the ipsilateral leg (if peripheral arterial disease is present or suspected, an ankle-brachial index should be obtained and documented)
• 7. Presence of open venous ulcer \> 50 cm2 area, suspicion for active ulcer infection, or visualization of bone or tendon within the ulcer in the ipsilateral leg
• 8. Inability to tolerate endovascular procedure due to acute illness, or general health
• 9. Severe allergy to iodinated contrast refractory to steroid premedication
• 10. Known allergy to stent or catheter components
• 11. Hemoglobin \< 8.0 g/dl, uncorrectable INR \> 3.05, or platelet count \< 75,000/ml
• 12. Severe renal impairment (on chronic dialysis or estimated GFR \< 30 ml/min)
• 13. Disseminated intravascular coagulation or other major bleeding diathesis
• 14. Pregnancy (positive pregnancy test)
• 15. Life-expectancy \< 6 months or chronically non-ambulatory for reasons other than PTS
• 16. Inability to provide informed consent or to comply with study assessments