C-TRACT Study; Chronic Venous Thrombosis; Relief with adjunctive catheter directed therapy

Are you eligible to participate in this study?

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

  • Conditions:
    Chronic Dvt
  • Age: Between 18 Year(s) - 99 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    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) either a Venous Clinical Severity Score (VCSS) > 8 or a Villalta PTS Scale score > 10 or an open venous ulcer);
    2. Ipsilateral iliac vein obstruction (occlusion or > 50% diameter stenosis), documented by traditional venogram, CT venogram, MR venogram, or intravascular ultrasound (IVUS) within the previous 1 month and after any endovascular procedure (if applicable).

You may not be eligible for this study if the following are true:

    1. Acute proximal DVT episode within the last 3 months
    2. Lack of suitable inflow into the common femoral vein (CFV) per the treating physician
    3. Documented obstruction (occlusion or > 50% diameter stenosis) of an IVC filter
    4. Chronic arterial limb ischemia (ankle-brachial index < 0.5 within the previous 1 month)
    5. Presence of open venous ulcer > 50 cm2 area, or suspicion for active ulcer infection
    6. Inability to tolerate endovascular procedure due to acute illness or general health
    7. Severe allergy to iodinated contrast refractory to steroid premedication
    8. Known allergy to stent or catheter components
    9. Hemoglobin < 8.0 g/dl, uncorrectable INR > 3.0 or platelet count < 75,000/ml
    10. Severe renal impairment (on chronic dialysis or estimated GFR < 30 ml/min)
    11. Disseminated intravascular coagulation or other major bleeding diathesis
    12. Pregnancy (positive pregnancy test)
    13. Life-expectancy < 6 months or chronically non-ambulatory for reasons other than PTS
    14. Inability to provide informed consent or to comply with study assessments.

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