Catheter-directed Thrombolysis Compared to Anticoagulation Alone for Acute Primary Iliofemoral Deep Venous Thrombosis

Exclusion Criteria

• •1. Age less than 18 years or greater than 75 years.
• •2. Symptom duration \> 14 days for the DVT episode in the index leg (i.e. non-acute DVT).
• •3. In the index leg: established PTS, or previous symptomatic DVT within the last 2 years.
• •4. In the contralateral (non-index) leg: symptomatic acute DVT a) involving the popliteal and/or tibial veins; or b) for which thrombolysis is planned as part of initial therapy.
• •5. Limb-threatening circulatory compromise.
• •6. PE with hemodynamic compromise (i.e. hypotension).
• •7. Inability to tolerate PCDT procedure due to severe dyspnea or acute systemic illness.
• •8. Allergy, hypersensitivity, or thrombocytopenia from heparin, rt-PA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
• •9. Hemoglobin \< 9.0 mg/dl, INR \> 1.6 before warfarin was started, or platelets \< 100,000 /ml.
• •10. Moderate renal impairment in diabetic patients (estimated GFR \< 60 ml/min) or severe renal impairment in non-diabetic patients (estimated GFR \< 30 ml/min).
• •11. Active bleeding, recent (\< 3 months) GI bleeding, severe liver dysfunction, bleeding diathesis.
• •12. Recent (\< 3 months) internal eye surgery or hemorrhagic retinopathy; recent (\< 10 days) major surgery, cataract surgery, trauma, CPR, obstetrical delivery, or other invasive procedure.
• •13. History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
• •14. Active cancer (metastatic, progressive, or treated within the last 6 months). Exception: patients with non-melanoma primary skin cancers are eligible to participate in the study.
• •15. Severe hypertension on repeated readings (systolic \> 180mmHg or diastolic \> 105 mmHg).
• •16. Pregnant (positive pregnancy test, women of childbearing potential must be tested).
• •17. Recently (\< 2 years or chronic non-ambulatory status.
• •18. Use of a thienopryridine antiplatelet drug (except clopidogrel) in the last 5 days.
• •19. Life expectancy \< 2 years or chronic non-ambulatory status.
• •20. Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance).