Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Washington University School of Medicine

Collaborator: Massachusetts General Hospital

Intervention(s):

  • Drug: Recombinant tissue plasminogen activator (rt-PA)

Phase:

Phase 3

Eligibility


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).

Ages Eligible for Study

16 Years - 75 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kamil Unver
6507259810
Not Recruiting