Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis

Inclusion Criteria:

   - Symptomatic proximal DVT involving the iliac, common femoral, and/or femoral vein.

Exclusion Criteria:

   - Age less than 16 years or greater than 75 years.

   - Symptom duration > 14 days for the DVT episode in the index leg (i.e., non-acute DVT).

   - In the index leg: established PTS, or previous symptomatic DVT within the last 2
   years.

   - In the contralateral (non-index) leg: symptomatic acute DVT a) involving the iliac
   and/or common femoral vein; or b) for which thrombolysis is planned as part of the
   initial therapy.

   - Limb-threatening circulatory compromise.

   - Pulmonary embolism with hemodynamic compromise (i.e., hypotension).

   - Inability to tolerate PCDT procedure due to severe dyspnea or acute systemic illness.

   - 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.

   - Hemoglobin < 9.0 mg/dl, INR > 1.6 before warfarin was started, or platelets <
   100,000/ml.

   - Moderate renal impairment in diabetic patients (estimated glomerular filtration rate
   [GFR] < 60 ml/min) or severe renal impairment in non-diabetic patients (estimated GFR
   < 30 ml/min).

   - Active bleeding, recent (< 3 mo) GI bleeding, severe liver dysfunction, bleeding
   diathesis.

   - Recent (< 3 mo) internal eye surgery or hemorrhagic retinopathy; recent (< 10 days)
   major surgery, cataract surgery, trauma, cardiopulmonary resuscitation, obstetrical
   delivery, or other invasive procedure.

   - History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation,
   aneurysm.

   - 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.

   - Severe hypertension on repeated readings (systolic > 180 mmHg or diastolic > 105
   mmHg).

   - Pregnant (positive pregnancy test, women of childbearing potential must be tested).

   - Recently (< 1 mo) had thrombolysis or is participating in another investigational drug
   study.

   - Use of a thienopyridine antiplatelet drug (except clopidogrel) in the last 5 days.

   - Life expectancy < 2 years or chronic non-ambulatory status.

   - Inability to provide informed consent or to comply with study assessments (e.g. due to
   cognitive impairment or geographic distance).