thrombo-embolic infra-inguinal arterial occlusion/ thrombosed leg artery
Conditions
Interventions
Group A (US-accelerated thrombolysis with 100.000 IU urokinase/h):
During angiography an US-enhanced thrombolysis delivery catheter will be
navigated into the thrombosed arterial segment over a guid
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with recently (less than 7 weeks) thrombosed femoro-popliteal or femoro-crural native arteries with ischemic complaints. 2. Patients with recently (less than 7 weeks) thrombosed femoro-popliteal or femoro-crural venous or prosthetic bypass grafts with ischemic complaints. 3. Limb ischemia class I and IIa according to the acute Rutherford classification. 4. Patients >18 years and
Exclusion criteria
Exclusion criteria: 1. Patients with isolated common femoral artery thrombosis including the origin of the superficial femoral artery and profunda femoral artery. 2. Patients with clinical complaints of lower limb ischemia due to thrombosis of femoro-popliteal or femoro-crural native arteries or femoro-popliteal and femoro-crural bypass grafts >7 weeks. 3. Patients with acute lower limb ischemia class IIb and III according to the acute Rutherford classification (see below). 4. Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated 5. Recent (110 mmHg, systolic blood pressure >200 mmHg) 8. Current malignancy 9. Patients with a history of prior life-threatening contrast medium reaction 10. Patients with uncorrected bleeding disorders (GI ulcera, mennorrhagia, liver failure) 11. Female patients of child bearing age not taking adequate contraceptives or currently breastfeeding. 12. Pregnancy 13. Any patient considered to be hemodynamically unstable at onset of procedure 14. Patients refusing treatment. 15. Patients currently participating in another investigational drug or device study that have not completed the entire follow up period. 16. Patients 85 years old. 17. Severe co-morbid condition with life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of hemorrhagic complications. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Technical success defined as >95% lysis of thrombus within 48 hours 2. Duration of catheter-derived thrombolysis needed for uninterrupted flow in the thrombosed infra-inguinal bypass graft or native artery with outflow via at least one crural artery 3. Amount of Urokinase (in IU) needed for uninterrupted flow. 4. 30-day mortality 5. 30-day patency of the target artery or bypass, as evidenced by Colour Flow Doppler Ultrasound (Duplex) 6. Conversion to open surgery 7. Distal thrombo-embolic complications | — |
Countries
Netherlands
Outcome results
None listed