Condition category
Circulatory System
Date applied
23/10/2009
Date assigned
08/12/2009
Last edited
17/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
-
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

http://www.antoniusziekenhuis.nl/

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes