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

Inclusion Criteria: Subjects must meet BOTH of these 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 siteprincipal investigator or a physician co-investigator; and b) substantial limitationof 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 byeither:

3. Occlusion or >50% 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 inthe ipsilateral iliac vein and non-phasic continuous Doppler flow in theipsilateral common femoral vein (CFV) in the presence of normal phasic Dopplerflow in the contralateral CFV.

Exclusion Criteria: Subjects meeting any of these criteria will be excluded.

1. Age less than 18 years

2. Acute ipsilateral proximal DVT episode within the last 3 months, or acutecontralateral DVT for which thrombolytic therapy is planned

3. Lack of suitable inflow into the ipsilateral common femoral vein per the treatingphysician

4. Previous stent placement in the infrarenal IVC or ipsilateral iliac or commonfemoral vein

5. Absence of PTS of at least moderate severity

6. Chronic arterial limb ischemia (ankle-brachial index < 0.5 within the previous 1month) in the ipsilateral leg (if peripheral arterial disease is present orsuspected, 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

Note - patients who initially meet an exclusion criterion can have eligibility re-evaluated on a subsequent occasion.