No registrations found.
ID
Source
Brief title
Health condition
Patients with acute and sub-acute (less than 7 weeks) thrombosed infra-inguinal bypass grafts of native arteries
Sponsors and support
Intervention
Outcome measures
Primary outcome
Occurrence of hemorrhagic complications.
Secondary outcome
1. Technical success defined as >95% lysis of thrombosed native artery or bypass within 48 hours
2. Duration of successful catheter-derived thrombolysis needed for uninterrupted flow in the thrombosed arterial segment with outflow via at least one crural artery.
3. Units Urokinase needed for technical success.
4. Distal thrombo-embolic complications
Study objective
Half dose Urokinase (50.000IE/h) will significantly reduce hemorrhagic complications compared with the standard dose Urokinase (100.000IE/h) with comparable technical success rate
Study design
Follow up visit will be 30 days after treatment
Intervention
50.000IE/h Urokinase
100.000IE/h Urokinase
Inclusion criteria
1. Patients with acute and sub-acute (less than 7 weeks) thrombosed infra-inguinal native arteries with ischemic complaints.
2. Patients with acute and sub-acute (less than 7 weeks) thrombosed infra-inguinal venous or prosthetic bypass grafts with ischemic complaints.
3. Limb ischemia class I and IIa according to the Rutherford classification (see below).
4. Patients >18 years and <85 years old.
5. Patients understand the nature of the procedure and provide written informed consent, prior to enrolment in the study
Exclusion criteria
1. Patients with isolated common femoral artery thrombosis including the origin of the superficial femoral artery and/ or 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 (see below)
4. Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
5. Recent (< 6 weeks) ischemic stroke or cerebral bleeding
6. Patients with recent (<6 weeks) surgery
7. Severe hypertension (diastolic blood pressure >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 < 18 years or >85 years old
17. Severe co-morbid condition with life expectancy < 1 month
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5914 |
| NTR-old | NTR6194 |
| CCMO | NL49466.100.15 |
| OMON | NL-OMON44501 |