Thromboembolic infra-inguinal disease Circulatory System
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 standardised intervals. Durin
Sponsors
St Antonius Hospital Nieuwegein (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, greater than 18 years and less than 85 years old 2. Patients with recently (between 1 and 7 weeks) thrombosed femoro-popliteal or femoro-crural native arteries or femoro-popliteal or femoro-crural venous or prosthetic bypass grafts with ischaemic complaints 3. Patients with acute lower limb ischaemia class I and IIa according to the Rutherford classification 4. Patients understand the nature of the procedure and provide written informed consent, prior to enrolment in the study
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 localised (less than 5 cm) emboli/occlusions in the native femoro-popliteal arteries 3. Patients with clinical complaints of acute lower limb ischaemia due to thrombosis of the femoro-popliteal or femoro-crural native arteries or femoro-popliteal or femoro-crural venous or prosthetic bypass grafts less than 1 week and greater than 7 weeks 4. Patients with acute lower limb ischaemia class IIb and III according to the Rutherford classification 5. Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contra-indicated 6. Recent (less than 6 weeks) ischaemic stroke or cerebral bleeding 7. Patients with recent (less than 6 weeks) surgery 8. Severe hypertension (diastolic blood pressure greater than 110 mmHg, systolic blood pressure greater than 200 mmHg) 9. Current malignancy 10. Patients with a history of prior life-threatening contrast medium reaction 11. Patients with uncorrected bleeding disorders (gastro-intestinal ulcer, menorrhagia, liver failure) 12. Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding 13. Pregnancy 14. Any patient considered to be haemodynamically 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 less than 18 years or greater than 85 years old 18. Severe co-morbid condition with life expectancy less than 1 month 19. Contra-indication for magnetic resonance imaging (MRI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of catheter-derived thrombolysis needed for uninterrupted flow in the thrombosed infra-inguinal native artery or bypass graft with outflow via at least one crural artery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Technical success defined as complete lysis of the thrombus of the native artery or bypass graft without distal thrombo-embolic complications 2. Number of units urokinasis needed for uninterrupted flow in the thrombosed infra-inguinal native artery or bypass graft with outflow via at least one crural artery 3. Thrombolysis induced haemorrhagic complications 4. 30-day mortality 5. Duration of hospital admission 6. Costs of hospital admission 7. 30-day patency of the target artery or bypass, as evidenced by magnetic resonance angiography (MRA) 8. Drop of serum fibrinogen concentration to below 1.0 g/L during procedure 7. Conversion to open surgery 8. Distal thromboembolic complications 9. Other complications | — |
Countries
Netherlands
Outcome results
None listed