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

Ki vehet részt

• 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
• Ipsilateral iliac vein obstruction documented within 12 months prior to consent by either:; Occlusion or >50% 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

Ki nem vehet részt

• Acute ipsilateral proximal DVT episode within the last 3 months, or acute contralateral DVT for which thrombolytic therapy is planned
• Previous stent placement in the infrarenal IVC or ipsilateral iliac or common femoral vein
• 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)
• 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
• Inability to tolerate endovascular procedure due to acute illness, or general health
• Severe allergy to iodinated contrast refractory to steroid premedication
• Known allergy to stent or catheter components
• Disseminated intravascular coagulation or other major bleeding diathesis
• Hemoglobin < 8.0 g/dl, uncorrectable INR > 3.0, or platelet count < 75,000/ml
• Severe renal impairment (on chronic dialysis or estimated GFR < 30 ml/min)
• Age less than 18 years
• Lack of suitable inflow into the ipsilateral common femoral vein per the treating physician
• Absence of PTS of at least moderate severity
• Pregnancy (positive pregnancy test)
• Life-expectancy < 6 months or chronically non-ambulatory for reasons other than PTS
• Inability to provide informed consent or to comply with study assessments; Note - patients who initially meet an exclusion criterion can have eligibility re-evaluated on a subsequent occasion