The use of ultrasound in the therapy of patients with blocked arteries of the lower limb.
Recruiting
- Conditions
- peripheral arterial occlusions, peripheral vascular disease, vascular disease, lower limb occlusive disease, acuut perifeer vaatlijden, acute vaatocclusie
- Registration Number
- NL-OMON27379
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.