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

Completed

Phase 3 Results N/A

Eligibility Criteria

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.
- PE 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 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, CPR, 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).