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

Trial ID or NCT#

NCT00790335

Status

RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 16 Years to 75 Years

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

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).