thrombo-embolic infra-inguinal arterial occlusion / thrombosed leg artery
Conditions
Interventions
Group A (standard thrombolysis): During angiography a thrombolysis delivery
catheter will be navigated proximally into the thrombus, followed by a control
angiography at standardized intervals. Duri
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with recently (between 1 and 7 weeks) thrombosed femoro-popliteal or femoro-crural native arteries with ischemic complaints. 2. Patients with recently (between 1 and 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 Rutherford classification for acute ischemia. 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 localized (7 weeks. 4. Patients with acute lower limb ischemia class IIb and III according to the Rutherford classification (see below). 5. Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated 6. Recent (110 mmHg, systolic blood pressure >200 mmHg) 9. Current malignancy 10. Patients with a history of prior life-threatening contrast medium reaction 11. Patients with uncorrected bleeding disorders (GI ulcera, mennorrhagia, liver failure) 12. Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding. 13. Pregnancy 14. Any patient considered to be hemodynamically unstable at onset of procedure 15. Patients refusing treatment. 16. Patients currently participating in another investigational drug or device study that have not completed the entire follow up period. 17. Patients 85 years old. 18. Severe co-morbid condition with life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Technical success defined as complete lysis of thrombus of the target vessel or bypass without distal thrombo-embolic complications. 2. Duration of catheter-derived thrombolysis needed for uninterrupted flow in the thrombosed native infra-inguinal artery or infra-inguinal bypass graft with outflow via at least one crural artery. 3. Number of units urokinasis needed for uninterrupted flow mentioned at point 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Thrombolysis induced hemorrhagic complications 2. 30-day mortality 3. Duration of hospital admission 4. Costs of hospital admission 5. 30-day patency of the target artery or bypass, as evidenced by Magnetic Resonance Angiography (MRA) 6. Drop of serum fibrinogen concentration to below 1.0 g/L during procedure 7. Conversion to open surgery 8. Distal thrombo-embolic complications | — |
Countries
Netherlands
Outcome results
None listed