Last updated on June 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Varicose Ulcer | Vascular Diseases | Thrombosis | Deep Vein Thrombosis | Venous stasis | Blood Clots | Venous Reflux | Venous Thrombosis | Venous Insufficiency
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Disabling (moderate-to-severe) PTS, defined by a) presence of chronic venous disease > 3 months duration in a leg with history of DVT; and b) either a Venous Clinical Severity Score (VCSS) > 8 or a Villalta PTS Scale score > 10 or an open venous ulcer); and
  2. Ipsilateral iliac vein obstruction documented within 3 months prior to screening by
  3. Occlusion or >50% stenosis of the iliac vein on venogram, CT venogram, MR venogram, or intravascular ultrasound (IVUS) or
  4. 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.

Exclusion Criteria:

  1. Age less than 18 years
  2. 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. Documented obstruction (occlusion or > 50% diameter stenosis) of an IVC filter
  5. Chronic arterial limb ischemia (ankle-brachial index < 0.5)
  6. Presence of open venous ulcer > 50 cm2 area, or suspicion for active ulcer infection in the ipsilateral leg
  7. Inability to tolerate endovascular procedure due to acute illness, or general health
  8. Severe allergy to iodinated contrast refractory to steroid premedication
  9. Known allergy to stent or catheter components
  10. Hemoglobin < 8.0 g/dl, uncorrectable INR > 3.5, or platelet count < 50,000/ml
  11. Severe renal impairment (estimated GFR < 30 ml/min)
  12. Disseminated intravascular coagulation or other major bleeding diathesis
  13. Pregnancy (positive pregnancy test)
  14. Life-expectancy < 6 months or chronically non-ambulatory for reasons other than PTS
  15. Inability to provide informed consent or to comply with study assessments Note - patients who initially meet an exclusion criterion can be re-screened at a later date, and may be enrolled if all eligibility criteria are met at that time.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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