Please select the eligibility criteria that correspond to the clinical trial below.
Title: The BERN Ultrasound-enhanced Thrombolysis for Ilio-Femoral Deep Vein Thrombosis versUs Standard Catheter Directed thromboLysis Trial (BERNUTIFUL-Trial)
Brief Summary: Patients with deep vein thrombosis (DVT) of the ilio-femoral veins have increased risk for developing post-thrombotic syndrome (PTS) and recurrent venous thromboembolism compared to more distal DVT. There's evidence that the early removal of the obstructing thrombus by catheter directed thrombolysis (CDT) reduces the risk of developing a PTS, and a higher degree of thrombolysis is associated with lower incidence of PTS, better quality of life and lower risk of recurrent venous thromboembolism. A further development is ultrasound-enhanced thrombolysis combining CDT with a sophisticated catheter system that employs high-frequency, low-dose ultrasound. In vitro experiments showed that adding ultrasound to thrombolytic drugs accelerates thrombolysis while Ultrasound exposure alone results in no thrombolysis, however the superiority of ultrasound-enhanced thrombolysis over standard CDT has never been formally assessed in vivo. The hypothesis for this study is that ultrasound-enhanced thrombolysis reaches a higher degree of thrombolysis than standard CDT in patients with symptomatic ilio-femoral DVT.


Options:
A: Inclusion Criteria:

* Symptomatic proximal DVT involving the iliac and/or common femoral vein, confirmed by Duplex Sonography, Angio-CT, Angio-MRI or Phlebography
* Written informed consent

Exclusion Criteria

* Age less than 18 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 post-thrombotic syndrome (PTS) or previous symptomatic DVT within the last 2 years.
* Limb-threatening circulatory compromise.
* PE with hemodynamic compromise (i.e., hypotension).
* Inability to tolerate catheter procedure due to severe dyspnea or acute systemic illness.
* Allergy, hypersensitivity, or thrombocytopenia from heparin, r-tPA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
* Known significant bleeding risk, or known coagulation disorder (including vitamin K antagonists with INR \> 2.0 and platelet count \< 100 000/mm3)
* Severe renal impairment (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.
* Severe hypertension on repeated readings (systolic \> 180 mmHg or diastolic \> 105 mmHg).
* Pregnant, lactation or parturition within the previous 30 days (positive pregnancy test, women of childbearing age must be tested or use a medically accepted method of birth control).
* Recently (\< 1 mo) had thrombolysis.
* Life expectancy \< 6 months or chronic non-ambulatory status.
* Participating in any other investigational drug or device study or previous enrollment in this study
* Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance).
* Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
B: 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).
C: Inclusion Criteria:

* All outpatients with an acute, symptomatic, distal DVT will be included in the study, provided they correspond to the following diagnostic and exclusion criteria, and they have signed an informed consent form.

Exclusion Criteria:

* Age less than 18 years
* Previously objectively diagnosed DVT or PE
* Distal DVT involving the tibioperoneal trunk (i.e. calf trifurcation)
* Clinically suspected pulmonary embolism
* Active cancer, receiving cancer treatment or cancer considered cured for \<6 months
* Ipsilateral or contralateral proximal DVT
* Indication for long-term anticoagulation (e.g. atrial fibrillation, mechanical heart valve...)
* Pregnancy
* Thrombocytopenia (platelet count \< 100 g/l)
* Impaired renal function (serum creatinine \> 180 micromol/l or clearance to creatinine less than 30 ml/min)
* Known hypersensitivity to heparin
* Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (gastric ulcer, cerebral malignant disease...)
* Treatment with daily NSAIDs (aspirin ≤160 mg/day permitted)
* Body weight \>115 kg or \<40 kg
* Treatment with therapeutic doses of anticoagulants for \>2 days, corresponding to: 2 injections of LMWH if once daily therapeutic LMWH used; 3 injections of LMWH if twice-daily therapeutic LMWH used; 1 dose of oral vitamin K antagonist (e.g. warfarin)
* Ongoing requirement for prophylactic dose thromboprophylaxis (e.g. acute post-op patient receiving thromboprophylaxis)
* Enrolled in another clinical trial within previous 30 days
* Inability or refusal to provide informed consent
D: Inclusion Criteria:

* Female and male patients
* Patients \>= 18 years
* Patiebts with diagnosis of acute DVT and who have an indication for anticoagulation therapy for at least 12 weeks, who are willing to participate in this study and are available for follow-up

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information.

Answer: A