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

Completed · Phase 3

Conditions studied: Deep Vein Thrombosis, Venous Thrombosis, Postphlebitic Syndrome, Venous Thromboembolism, Post Thrombotic Syndrome

In brief

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.

Key facts

Study ID

NCT00790335

Run by

Washington University School of Medicine

People needed

692

Starts

2009-11-01

Expected to finish

2017-01-01

Last updated by the study team

2018-03-29

Who can join

Age: 16 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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).

Where it is running

• St. Joseph Hospital — Orange, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Danbury Hospital — Danbury, Connecticut, United States
• Eastern Connecticut Hematology and Oncology Associates — Norwich, Connecticut, United States
• Christiana Care Health Systems — Newark, Delaware, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Mease Countryside Hospital — Clearwater, Florida, United States
• Baptist Cardiac & Vascular Institute — Miami, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Florida Hospital-Tampa Division-Pepin Heart Institute and Dr. Kiran C. Patel Research Institute — Tampa, Florida, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Adventist Midwest Health — Hinsdale, Illinois, United States
• Southern Illinois University — Springfield, Illinois, United States
• Central DuPage Hospital — Winfield, Illinois, United States
• CorVasc — Indianapolis, Indiana, United States
• University of Iowa Carver's College of Medicine — Iowa City, Iowa, United States
• St. Elizabeth Healthcare of Northern Kentucky — Florence, Kentucky, United States
• Maine Medical Center — Portland, Maine, United States
• University of Maryland — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Ann Arbor Veteran's Administration Health System — Ann Arbor, Michigan, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Arrowhead Hospital/Phoenix Heart, PLLC — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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