Contact information
Type
Scientific
Primary contact
Dr Jean-Paul P M de Vries
ORCID ID
Contact details
St Antonius Hospital Nieuwegein
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands
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j.vries@antoniusziekenhuis.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NL28737.100.09
Study information
Scientific title
Dutch randomised trial comparing standard catheter-directed thrombolysis versus ultrasound-accelerated thrombolysis for thromboembolic infra-inguinal disease (DUET)
Acronym
DUET
Study hypothesis
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
Ethics Committee of the St. Antonius Hospital Nieuwegein, 13/10/2009, ref: R-09.17A
Study design
Multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/11/2009
Overall trial end date
01/11/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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)
Recruitment start date
01/11/2009
Recruitment end date
01/11/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
St Antonius Hospital Nieuwegein
Nieuwegein
3435 CM
Netherlands
Sponsor information
Organisation
St Antonius Hospital Nieuwegein (Netherlands)
Sponsor details
PO Box 2500
Koekoekslaan 1
Nieuwegein
3435 CM
Netherlands
+31 (0)88 320 30 00
j.vries@antoniusziekenhuis.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
St Antonius Hospital Nieuwegein (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21255459
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21792154
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25775686
Publication citations
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Protocol
Schrijver AM, Reijnen MM, van Oostayen JA, Nolthenius RP, van der Valk PH, Hoksbergen AW, Lely RJ, Fioole B, Vroegindeweij D, van Leersum M, de Vries JP, Dutch randomized trial comparing standard catheter-directed thrombolysis versus ultrasound-accelerated thrombolysis for thromboembolic infrainguinal disease (DUET): design and rationale., Trials, 2011, 12, 20, doi: 10.1186/1745-6215-12-20.
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Results
Schrijver A, Vos J, Hoksbergen AW, Fioole B, Fritschy W, Hulsebos R, De Jong S, Reijnen MM, De Vries JP, Ultrasound-accelerated thrombolysis for lower extremity ischemia: multicenter experience and literature review., J Cardiovasc Surg (Torino), 2011, 52, 4, 467-476.
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Results
Schrijver AM, van Leersum M, Fioole B, Reijnen MM, Hoksbergen AW, Vahl AC, de Vries JP, Dutch Randomized Trial Comparing Standard Catheter-Directed Thrombolysis and Ultrasound-Accelerated Thrombolysis for Arterial Thromboembolic Infrainguinal Disease (DUET), J Endovasc Ther, 2015 , 22, 1, 87-95.