Dutch randomized trial comparing standard catheter-directed thrombolysis versus ultrasound-accelerated thrombolysis for thrombo-embolic infra-inguinal disease.
- Conditions
- thrombo-embolic infra-inguinal arterial occlusion / thrombosed leg artery10014523
- Registration Number
- NL-OMON35325
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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 < 85 years old.
5. Patients understand the nature of the procedure and provide written informed consent, prior to enrolment in the study
1. Patients with isolated common femoral artery thrombosis including the origin of the superficial femoral artery and profunda femoral artery.
2. Patients with localized (<5 cm) emboli / occlusions in the native femoropopliteal arteries
3. Patients with clinical complaints of lower limb ischemia due to thrombosis of the native femoro-crural arteries or femoro-popliteal and femoro-crural bypass grafts <1 week and >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 (< 6 weeks) ischemic stroke or cerebral bleeding
7. Patients with recent (<6 weeks) surgery
8. Severe hypertension (diastolic blood pressure >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 < 18 years or >85 years old.
18. Severe co-morbid condition with life expectancy < 1 month
19. Contra-indication for MRI
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Technical success defined as complete lysis of thrombus of the target vessel<br /><br>or bypass without distal thrombo-embolic complications.<br /><br>2. Duration of catheter-derived thrombolysis needed for uninterrupted flow in<br /><br>the thrombosed native infra-inguinal artery or infra-inguinal bypass graft with<br /><br>outflow via at least one crural artery.<br /><br>3. Number of units urokinasis needed for uninterrupted flow mentioned at point<br /><br>1.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Thrombolysis induced hemorrhagic complications<br /><br>2. 30-day mortality<br /><br>3. Duration of hospital admission<br /><br>4. Costs of hospital admission<br /><br>5. 30-day patency of the target artery or bypass, as evidenced by Magnetic<br /><br>Resonance Angiography (MRA)<br /><br>6. Drop of serum fibrinogen concentration to below 1.0 g/L during procedure<br /><br>7. Conversion to open surgery<br /><br>8. Distal thrombo-embolic complications </p><br>