Te demonstrate that the use of US-accelerated catheter-derived thrombolysis in patients with recently (between 1 and 7 weeks) thrombosed infra-inguinal bypass grafts or native arteries will significantly reduce (at least 12 hours) therapy time…
ID
Source
Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Technical success defined as complete lysis of thrombus of the target vessel
or bypass without distal thrombo-embolic complications.
2. Duration of catheter-derived thrombolysis needed for uninterrupted flow in
the thrombosed native infra-inguinal artery or infra-inguinal bypass graft with
outflow via at least one crural artery.
3. Number of units urokinasis needed for uninterrupted flow mentioned at point
1.
Secondary outcome
1. Thrombolysis induced hemorrhagic complications
2. 30-day mortality
3. Duration of hospital admission
4. Costs of hospital admission
5. 30-day patency of the target artery or bypass, as evidenced by Magnetic
Resonance Angiography (MRA)
6. Drop of serum fibrinogen concentration to below 1.0 g/L during procedure
7. Conversion to open surgery
8. Distal thrombo-embolic complications
Background summary
Thrombosis of an infra-inguinal bypass graft or the native lower leg arteries
has been associated with a high rate of limb loss and significant morbidity and
mortality. Traditional therapy consisted of thrombectomy and graft revision,
whereas currently catheter-directed thrombolysis is often used. Major
advantages of catheter-dericted thrombolysis as compared to surgery are:
less-invasive character, gentler clot removal, clearing out and visualizing
the distal runoff vessels and the involved segment, thereby revealing the
underlying lesion, easy combination with additional endovascular intervention
to treat stenosis of the inflow or outflow arteries. Drawbacks might be: higher
costs, longer time needed to revascularization compared to surgery,
thrombolysis induced hemorrhagic complications, a small but significant
incidence of stroke, and renal dysfunction related to repeated angiography.
To reduce these limitations reduction of thrombolytic therapy time would be
necessary. Based on available literature US-accelerated thrombolysis has been
shown to reduce therapy time of patients with deep vein thombosis by increasing
clot permeability to the thrombolytic agent. A similar result was seen in a
recent recies of patients with an acute obstruction of the native lower limb
arteries. However, no randomized trials have been performed in the arterial
system so far.
Study objective
Te demonstrate that the use of US-accelerated catheter-derived thrombolysis in
patients with recently (between 1 and 7 weeks) thrombosed infra-inguinal bypass
grafts or native arteries will significantly reduce (at least 12 hours) therapy
time compared to standard thrombolysis alone without increasing complication
rate.
Study design
Multi centre randomized trial.
Intervention
Group A (standard thrombolysis): During angiography a thrombolysis delivery
catheter will be navigated proximally into the thrombus, followed by a control
angiography at standardized intervals. During each control angiography the tip
of the thrombolysis catheter will be repositioned proximally in the remaining
thrombus.
Group B (US-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 US core wire and thrombolytic therapy will be
started. Likewise a control angiography will be performed at standardized
intervals.
Study burden and risks
The EKOS endowave system has been extensively used for the treatment of venous
thrombosis. Furthermore, the EKOS endowave system has been used for the
treatment of arterial thrombosis. However, until now no randomized trials have
been performed. So far, no serious adverse events of the EKOS system itself
have been published. It is believed that the risks of US-accelerated
thrombolysis will be similar or less compared to those associated with standard
thrombolysis. If not participating in this trial, patients would be eligible
for standard thrombolysis therapy.
Koekoekslaan 1
3430 EM Nieuwegein
NL
Koekoekslaan 1
3430 EM Nieuwegein
NL
Listed location countries
Age
Inclusion criteria
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
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 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28737.100.09 |