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SNCTP000002276 | NCT03192332 | BASEC2017-00974

Direkte Entfernung von Blutgerinnseln im Gehirn (mechanische Thrombektomie) beim ischämischen Hirninfarkt

Data source: BASEC (Imported from 24.06.2024), WHO (Imported from 20.06.2024)
Changed: Dec 23, 2023, 4:19 PM
Disease category: Brain diseases (non cancer), Nervous System diseases

Brief description of trial (Data source: BASEC)

Die Studie untersucht die Behandlung bei Patienten mit einem akutem Hirnschlag aufgrund eines Hirngefässverschlusses (sogenannter ischämischer Hirninfarkt). Ein ischämischer Hirninfarkt wird durch den Verschluss eines oder mehrerer Blutgefässe im Gehirn verursacht. Die Blutgefässe werden dabei durch ein Blutgerinnsel verstopft und das Blut kann nicht mehr frei zirkulieren. Dadurch kommt es in dem von diesen Gefässen versorgten Hirngebiet zu einer Unterversorgung mit Blut und Sauerstoff. Hält die Unterversorgung länger als einige Minuten an besteht die Gefahr, dass Nervenzellen absterben. Daher ist der akute ischämische Hirninfarkt eine lebensbedrohende Situation. Wir wollen beim ischämischen Hirninfarkt untersuchen, wie gut die direkte Entfernung des Blutgerinnsels im Hirngefäss mit einem speziellen Katheter ist. Das Blutgerinnsel wird dabei mithilfe dieses Katheters aus den Hirngefässen entfernt und die Durchblutung im Gehirn wiederhergestellt. Danach wird der Katheter wieder entfernt. Mit dieser klinischen Studie wollen wir die Wirksamkeit dieser Behandlungsstrategie (direkte Entfernung des Blutgerinnsels im Hirngefäss) mit derjenigen der Standardbehandlung vergleichen. Als Standardbehandlung wird das Blutgerinnsel im Gehirn zuerst medikamentös „aufgeweicht“ was als intravenöse Thrombolyse (Gabe von Blutgerinnsel auflösenden Medikamenten) bezeichnet wird. Danach wir das Blutgerinnsel, wie oben beschrieben, mit einem Katheter aus dem Hirngefäss entfernt. Die Studienteilnehmer werden nach dem Zufallsprinzip entweder der Studienbehandlung oder der Standardbehandlung zugeteilt (50% in jeder Gruppe).

Health conditions investigated(Data source: BASEC)

Aktuer Hirnschlag (ischämischer Hirninfarkt), Verschluss von Blutgefässen im Gehirn, direkte Entfernung von Blutgerinnseln

Health conditions (Data source: WHO)

Ischemic Stroke

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Direkte Entfernung des Blutgerinnsels im Hirngefäss oder Gabe von Blutgerinnsel auflösenden Medikamenten und Entfernung des Blutgerinnsels im Hirngefäss

Interventions (Data source: WHO)

Device: Stent-retriever thrombectomy with revascularization device of the Solitaire™ type;Drug: Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA)

Criteria for participation in trial (Data source: BASEC)

Ischämischen Hirninfarkt
über 18 Jahre alt
Therapiebeginn innerhalb von 4 Stunden und 30 Minuten nach Symptombeginn

Exclusion criteria (Data source: BASEC)

Akute Hirnblutung
Vorbehandlung mit Blutgerinnsel auflösenden Medikamenten
Überempfindlichkeit auf Kontrastmittel (Medikament zur Darstellung der Blutgefässe beim Röntgen)

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

1. Informed consent as documented by signature

2. Age = 18

3. Clinical signs consistent with an acute ischemic stroke

4. Neurological deficit with a NIHSS of = 5 and < 30 (deficits judged to be clearly
disabling at presentation)

5. Patient is eligible for intravenous thrombolysis

6. Patient is eligible for endovascular treatment

7. Randomization no later than 4 hours 15 minutes after stroke symptom onset and
initiation of IV t-PA must be started within 4 hours 30 minutes of stroke symptoms
onset (onset time is measured from the time when the subject was last seen well)

8. Occlusion (TICI 0-1) of the intracranial internal carotid artery (ICA), the M1 segment
of the middle cerebral artery (MCA), or both confirmed by CT or MR angiography,
accessible for MT

9. Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) greater than or
equal to 4 (= 4) based on baseline CT or MR imaging (MRI) (a region has to have
diffusion abnormality in 20% or more of its volume to be considered MR-ASPECTS
positive)

Exclusion Criteria:

1. Acute intracranial hemorrhage

2. Any contraindication for IV t-PA

3. Pre-treatment with IV t-PA

4. In-hospital stroke

5. Pregnancy or lactating women. A negative pregnancy test before randomization is
required for all women with child-bearing potential.

6. Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals,
or their alloys

7. Known current participation in a clinical trial (investigational drug or medical
device)

8. Renal insufficiency as defined by a serum creatinine > 2.0 mg/dl (or 176.8 µmol/l) or
glomerular filtration rate (GFR) < 30 mL/min or requirement for hemodialysis or
peritoneal dialysis

9. Severe comorbid condition with life expectancy less than 90 days at baseline

10. Known advanced dementia or significant pre-stroke disability (mRS score of =2)

11. Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living
abroad)

12. Comorbid disease or condition that would confound the neurological and functional
evaluations or compromise survival or ability to complete follow-up assessments.

13. Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol
(defined as regular or daily consumption of more than four alcoholic drinks per day).

14. Known history of arterial tortuosity, pre-existing stent, other arterial disease
and/or known disease at the femoral access site that would prevent the device from
reaching the target vessel and/or preclude safe recovery after MT

15. Radiological confirmed evidence of mass effect or intracranial tumor (except small
meningioma)

16. Radiological confirmed evidence of cerebral vasculitis

17. CTA or MRA evidence of carotid artery dissection

18. Evidence of additional distal intracranial vessel occlusion in another territory (i.e.
A2 segment of anterior cerebral artery or M3, M4 segment of MCA) on initial NCCT/MRI
or CTA/MRA

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03192332

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03192332
Further information on trial

Date trial registered

Jun 12, 2017

Incorporation of the first participant

Nov 29, 2017

Recruitment status

Completed

Academic title (Data source: WHO)

Solitaire™ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).

Phase (Data source: WHO)

N/A

Primary end point (Data source: WHO)

Score in modified Rankin Scale (mRS)

Secundary end point (Data source: WHO)

Mortality;Modified Rankin Scale (mRS) shift analysis;National Institute of Health Score Scale (NIHSS);Thrombolysis in Cerebral Infarction (TICI) scale;Serious adverse events;Intracranial hemorrhage;Quality of life assessed by questionnaire;Overall costs incurred during hospitalisation

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Aarau, Bern, Geneva, Lausanne, Lugano, St. Gallen, Zurich

Countries (Data source: WHO)

Austria, Canada, Finland, France, Germany, Spain, Switzerland, United Kingdom

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Prof. Dr. med. Urs Fischer
+41 31 632 03 64
urs.fischer@insel.ch

Contact for general information (Data source: WHO)

Urs Fischer, Prof. Dr.;Jan Gralla, Prof. Dr.;Patricia Plattner, MSc
Dept. of Neurology, Inselspital Bern;Dept. of Neuroradiology, Inselspital Bern
+41 31 632 39 70
patricia.plattner@insel.ch

Contact for scientific information (Data source: WHO)

Urs Fischer, Prof. Dr.;Jan Gralla, Prof. Dr.;Patricia Plattner, MSc
Dept. of Neurology, Inselspital Bern;Dept. of Neuroradiology, Inselspital Bern
+41 31 632 39 70
patricia.plattner@insel.ch

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Bern

Date of authorisation by the ethics committee

30.08.2017

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2017-00974
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