Acute thrombo-embolic occlusion of one of the infra-inguinal arteries
Conditions
Interventions
Trade Name: Urokinase
Product Name: Medacinase
Product Code: RVG 11730
Pharmaceutical Form: Powder for concentrate for solution for infusion
Sponsors
Sint Antonius Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with acute and sub-acute (less than 7 weeks) thrombosed femoro-popliteal or femoro-crural native arteries with ischemic complaints. 2. Patients with acute and sub-acute (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 Rutherford classification. 4. Patients >18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 62
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 Rutherford classification 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 being 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 < 1 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Effectiveness of lower dose Urokinase, also compared to duration of treatment and the total units of Urokinase needed to treat.;Primary end point(s): Thrombolysis induced hemorrhagic complications.;Timepoint(s) of evaluation of this end point: During treatment ;Main Objective: To demonstrate that the use of US-accelerated catheter-directed thrombolysis (EKOS EndoWave™) in patients with acute and sub-acute (less than 7 weeks) thrombosed infra-inguinal bypass grafts or native arteries with half the dose urokinase (50.000 I.U./h) will significantly reduce hemorrhagic complication rate compared with US-accelerated catheter-directed thrombolysis with the standard dose urokinase (100.000 I.U. /h) with comparable technical success rates. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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 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 ;Timepoint(s) of evaluation of this end point: during the treatment and at follow-up visit 30 days after treatment. | — |
Countries
Netherlands
Contacts
Public ContactI.M. van Dop
Sint Antonius Hospital
Outcome results
None listed