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

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if the use of adjunctive Pharmacomechanical Catheter Directed Thrombolysis, which includes the intrathrombus administration of rt-PA--Activase (Alteplase),can prevent the post-thrombotic syndrome(PTS)in patients with symptomatic proximal deep vein thrombosis(DVT)as compared with optimal standard DVT therapy alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: Boston Scientific Corporation; BSN Medical Inc; Genentech, Inc.; Massachusetts General Hospital; McMaster University; Medtronic - MITG; Mid America Heart Institute; National Heart, Lung, and Blood Institute (NHLBI); Ontario Clinical Oncology Group (OCOG); Society of Interventional Radiology Foundation
• Treatments: Plasminogen; Tissue Plasminogen Activator

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.

• 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).