Table 2

Eligibility criteria

Inclusion criteria
  • Men and women older than 18 and younger than 85 years

  • Patients with a maximum of 2 weeks of symptoms for lower limb ischaemia due to thrombosed/occluded iliofemoral, femoropopliteal or femorocrural native arteries or iliofemoral, femoropopliteal or femorocrural venous or prosthetic bypass grafts

  • Patients appropriate for thrombolysis, that is, with acute lower limb ischaemia class I and IIa according to the Rutherford classification

  • Patients who understand the nature of the procedure and provide written informed consent before enrolment in the study

Exclusion criteria
  • Patients with clinical complaints of acute lower limb ischaemia due to thrombosis of iliofemoral, femoropopliteal or femorocrural native arteries, or iliofemoral, femoropopliteal or femorocrural venous or prosthetic bypass grafts for >2 weeks

  • Patients with thrombosed popliteal aneurysms

  • Patients with absolute contraindications for administration of antiplatelet therapy, anticoagulants or thrombolytics

  • History of recent (<6 weeks) ischaemic stroke, cerebral haemorrhagic or myocardial infarction

  • Patients with recent (<6 weeks) surgery

  • Severe hypertension (diastolic blood pressure >110 mm Hg and/or systolic blood pressure >200 mm Hg)

  • Current malignancy or severe comorbid condition with a life expectancy of <6 months

  • Patients with uncorrected bleeding disorders (gastrointestinal ulcer, menorrhagia, liver failure)

  • Women with childbearing potential not taking adequate contraceptives or currently breast feeding

  • Pregnancy

  • Patients who are currently participating in another investigational drug or device study

  • Patients younger than 18 years or older than 85 years

  • Patients with contraindications for Luminity microbubbles, that is:

    • Hypersensitivity to perflutren or to any of the components of Luminity

    • Recent acute coronary syndrome or clinically unstable ischaemic cardiac disease, including evolving or ongoing myocardial infarction, unstable angina at rest within the last seven days, significant worsening of cardiac symptoms within the last seven days, recent coronary artery intervention or other factors suggesting clinical instability (eg, recent deterioration of ECG, laboratory or clinical findings), acute cardiac failure, class III/IV cardiac failure or severe rhythm disorders

    • Patients known to have right-to-left cardiac shunts, severe pulmonary hypertension (pulmonary artery pressure>90 mm Hg), uncontrolled systemic hypertension and in patients with Global Initiative for Obstructive Lung Disease (GOLD) stage IV chronic obstructive pulmonary disease, diffuse interstitial fibrosis or adult respiratory distress syndrome

    • Patients with cardiovascular instability where dobutamine is contraindicated