Standard catheter-directed thrombolysis versus ultrasound-accelerated thrombolysis for thombo-embolic infra-inguinal disease

Completed

• Conditions: Thromboembolic infra-inguinal disease; Circulatory System

• Registration Number: ISRCTN72676102
• Lead Sponsor: St Antonius Hospital Nieuwegein (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-08
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified