thrombosis Vascular occlusion
Conditions
Interventions
The experimental protocol consists of the standard thrombolysis protocol, i.e.
the local placement of a catheter and sheath in the *angio-room* just near the
occlusion or thrombus of the affected ar
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Men and women older than 18 years and younger than 85 years old * Patients with a maximum of 2 weeks complaints due to lower limb ischemia due to thrombosed/occluded iliofemoral, femoropopliteal or femorocrural native arteries or femoropopliteal or femorocrural venous or prosthetic bypass grafts * Anatomic suitability duplex ultrasound in case of iliac occlusion * Patients fit for thrombolysis i.e. with acute lower limb ischemia class I and IIa according to the Rutherford classification (see attachment II) * Patients understand the nature of the procedure and provide written informed consent before enrolment in the study
Exclusion criteria
Exclusion criteria: * Patients with clinical complaints of acute lower limb ischemia due to thrombosis of the iliofemoral, femoropopliteal or femorocrural native arteries, or femoropopliteal or femorocrural venous or prosthetic bypass grafts more than 2 weeks * Patients with iliac occlusions anatomically not suitable for duplex ultrasound * Patients with thrombosed popliteal aneurysms * Patients with contra-indications for the administration of antiplatelet therapy, anticoagulants or thrombolytics * Recent (less than 6 weeks) ischemic stroke, cerebral bleeding or myocardial infarction * Patients with recent (less than 6 weeks) surgery * Severe hypertension (diastolic blood pressure greater than 110 mm Hg, systolic blood pressure higher than 200 mm Hg) * Current malignancy or severe comorbid condition with a life expectancy of less than 6 months * Patients with uncorrected bleeding disorders (gastrointestinal ulcer, menorrhagia, liver failure) * Women with child-bearing potential not taking adequate contraceptives or currently breastfeeding * 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 contra-indications for Luminity microbubbles i.e. * Hypersensitivity to perflutren or other components of Luminity * Recent acute coronary syndrome or clinically unstable ischemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (for example, 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 shunts, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension, and in patients with GOLD Stage IV COPD, diffuse interstitial fibrosis or adult respiratory distress syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main endpoints will be the duration of thrombolysis needed for uninterrupted flow in the thrombosed native artery or bypass graft with outflow through at least 1 crural artery and microcirculation of the lower limb as measured by Laser Doppler Flowmetry on the skin of the lower limb. Furthermore, Severe Adverse Events (haemorrhagic complications, allergic reactions, in hospital mortality directly related to the treatment) and amputation-free rate at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be the success rate, distal thromboembolic complications, other complications, 30 day mortality rate, conversion to open surgery, duration of hospital admission, serum fibrinogen concentrations, pain scores and quality of life. | — |
Countries
Netherlands
Outcome results
None listed