C-TRACT Trial – Protocol Synopsis

Principal Investigator: Suresh Vedantham, MD

Title: Chronic Venous Thrombosis: Relief with Adjunctive Catheter-Directed Therapy (C-TRACT)

Objective: Determine if the use of imaging-guided endovascular therapy (EVT) is an effective strategy with which to reduce Post-Thrombotic Syndrome (PTS) disease severity and improve quality of life (QOL) in patients with established disabling iliac-obstructive post-thrombotic syndrome (DIO-PTS).

Design: Multicenter, parallel two-arm, assessor-blind, randomized (1:1) clinical trial: EVT versus no-EVT.

Sample Size: 250 patients

Funding: National Heart Lung and Blood Institute (NHLBI)/ National Institutes of Health (NIH)

Number of Centers: Approximately 20-40 sites

Trial Inclusion Criteria:

Participants must meet BOTH of these criteria to be eligible for enrollment.

  1. 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 investitor;  and
  2. Ipsilateral iliac vein obstruction,documented within 12 months prior to concent by either:
    1. Occlusion 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.

Exclusion Criteria:

Participants meeting any of these criteria will be excluded (all times are relative to screening date):

  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 (CFV) 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 severty
  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 suspect, an ankle-brachial index should be obtained and documented)
  7. Presence of an 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 > 3.0 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.