Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis
Condition: Deep Vein Thrombosis; Venous Thrombosis; Postphlebitic Syndrome; Venous Thromboembolism; Post Thrombotic Syndrome
MeSH terms: Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome; Syndrome
Intervention: Recombinant tissue plasminogen activator (rt-PA)
Intervention description: Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.
Intervention MeSH terms: Tissue Plasminogen Activator; Plasminogen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 692.0
Sex: All
Minimum age: 16 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: deep vein thrombosis; deep venous thrombosis; post thrombotic syndrome; blood clot; thrombolysis; tissue plasminogen activator; rt-PA; Activase; mechanical thrombectomy; pharmacomechanical; ATTRACT

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.
    

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.

          -  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).