Standard catheter-directed thrombolysis versus ultrasound-accelerated thrombolysis for thombo-embolic infra-inguinal disease
| ISRCTN | ISRCTN72676102 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72676102 |
| Secondary identifying numbers | NL28737.100.09 |
- Submission date
- 23/10/2009
- Registration date
- 08/12/2009
- Last edited
- 17/03/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jean-Paul P M de Vries
Scientific
Scientific
St Antonius Hospital Nieuwegein
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands
| j.vries@antoniusziekenhuis.nl |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Dutch randomised trial comparing standard catheter-directed thrombolysis versus ultrasound-accelerated thrombolysis for thromboembolic infra-inguinal disease (DUET) |
| Study acronym | DUET |
| Study objectives | The use of ultrasound-accelerated catheter-derived thrombolysis in patients with recently (between 1 and 7 weeks) thrombosed infra-inguinal native arteries or bypass grafts will significantly reduce (at least 12 hours) therapy time compared to standard thrombolysis alone without increasing complication rate. |
| Ethics approval(s) | Ethics Committee of the St. Antonius Hospital Nieuwegein, 13/10/2009, ref: R-09.17A |
| Health condition(s) or problem(s) studied | Thromboembolic infra-inguinal disease |
| Intervention | 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. During each control angiography the tip of the thrombolysis catheter will be repositioned proximally in the remaining thrombus. Group B (ultrasound-accelerated thrombolysis): During angiography a thrombolysis delivery catheter will be navigated into the thrombosed segment with a guide wire in such a way that the treatment zone traverses the entire clot and the tip lies distal to the thrombus. After final positioning, the guide wire will be exchanged for a matching ultrasound-core wire and thrombolytic therapy will be started. Likewise a control angiography will be performed at standardised intervals. The total duration of follow-up will be 1 month. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/11/2009 |
| Completion date | 01/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/11/2009 |
| Date of final enrolment | 01/11/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
St Antonius Hospital Nieuwegein
Nieuwegein
3435 CM
Netherlands
3435 CM
Netherlands
Sponsor information
St Antonius Hospital Nieuwegein (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
PO Box 2500
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands
| Phone | +31 (0)88 320 30 00 |
|---|---|
| j.vries@antoniusziekenhuis.nl | |
| Website | http://www.antoniusziekenhuis.nl/ |
"ROR" |
https://ror.org/01jvpb595 |
Funders
Funder type
Hospital/treatment centre
St Antonius Hospital Nieuwegein (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/01/2011 | Yes | No | |
| Results article | results | 01/08/2011 | Yes | No | |
| Results article | results | 01/02/2015 | Yes | No |
