Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke(AIS)

10. september 2018 opdateret af: Zhuhai Tonbridge Medical Tech. Co., Ltd.

The Efficacy and Safety Study of Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke

The study is a prospective, multi-center, stratified randomized, single-blind, parallel assignment, active control, non-inferiority trial. Patients are randomized 1 : 1 to either stent retriever(TonbridgeMT) or Solitaire™ for endovascular therapy for AIS. The study aims to evaluate the benefit and safety of stent retriever(TonbridgeMT) for AIS therapy, as compared to Solitaire™.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The main objective is to determine whether stent retriever(TonbridgeMT) will have non-inferior successful recanalization rate compared to Solitaire™ when applied to endovascular therapy for AIS.

The secondary objectives is to verify whether there isn't significant differences in time to achieve recanalization, NIHSS score, mRS score, and transportation performance between stent retriever(TonbridgeMT) and Solitaire™ when applied to endovascular therapy for AIS.

The third objectives is to verify whether there isn't significant differences in the rate of symptomatic intracranial hemorrhage, subarachnoid hemorrhage, adverse event(AE), serious adverse event(SAE), actual condition of AE and device deficiencies between stent retriever(TonbridgeMT) and Solitaire™ when applied to endovascular therapy for AIS.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

220

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
      • Beijing, Kina
        • The 306th Hospital of Chinese PLA
      • Changchun, Kina
        • The First Hospital of Jilin University
      • Changchun, Kina
        • China-Japan Union Hospital
      • Changzhou, Kina
        • The First People's Hospital of Changzhou
      • Guangzhou, Kina
        • The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
      • Guiyang, Kina
        • The Affiliated Hospital of Guizhou Medical University
      • Hangzhou, Kina
        • Hangzhou First People's Hospital
      • Hanzhou, Kina
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Nanjing, Kina
        • Nanjing First Hospital Affiliated to Nanjing Medicine University
      • Nanning, Kina
        • Nanning People's Hospital
      • Wuhan, Kina
        • The Third People's Hospital of Hubei Province
      • Xi'an, Kina
        • Tangdu Hospital
      • Zhengzhou, Kina
        • Henan Provincial People's Hospital
      • Zhengzhou, Kina
        • The First Affiliated Hospital of Zhengzhou University
      • Zhongshan, Kina
        • Zhongshan People's Hospital
      • Zhuhai, Kina
        • The Fifth Affiliated Hospital Sun Yat-Sen University
    • Shanghai
      • Shanghai, Shanghai, Kina
        • Changhai Hospital of Shanghai

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. 18≤ages≤80;
  2. Baseline NIHSS score obtained prior to randomization must be lower than 30 points;
  3. Acute occlusion(TICI 0-1) of the intracranial segment of internal carotid artery(ICA), or M1/M2 middle cerebral artery(MCA), or A1/A2 anterior cerebral artery(ACA), as evidenced by digital subtraction angiography(DSA);
  4. Patient treatable within 6 hours of symptom onset(symptoms onset is defined as point in time the patient was last seen well (at baseline)) can accept the complete femoral artery puncture;
  5. Pre-AIS mRS score lower than 2.

Exclusion Criteria:

  1. Computed tomography (CT) or magnetic resonance imaging (MRI) evidence of intracranial hemorrhage or massive cerebral infarction (ASPECTS score of<6 or infarct volume≥70ml or volume>1/3 blood supplying areas of MCA on CT/diffusion weighted imaging(DWI);
  2. DSA evidence of simultaneous acute bilateral carotid occlusion;
  3. DSA evidence of occlusions in the initial segment of carotid artery or carotid artery dissection or arteritis;
  4. DSA evidence of tortuosity of cervical vessels precluding device delivery/deployment;
  5. Hypertension (Systolic blood pressure(SBP)>185 mm Hg or diastolic blood pressure(DBP)>110 mm Hg) after using drug;
  6. Platelet count<40,000/μL and use of Novel Anticoagulant with International Normalized Ratio(INR)>3.0;
  7. Random blood glucose of<2.7mmol/L or>22.2mmol/L;
  8. Patients with heart or lung or liver or renal failure or other sever disease(intracranial tumors, cerebral arteriovenous malformation (AVM), systemic infection, active disseminated intravascular coagulation, myocardial infarction within the past 12 months before enrollment, history of sever psychosis);
  9. Patients who will not cooperate or tolerate interventional operation;
  10. Anticipated life expectancy of less than 90 days;
  11. Allergy to contrast medium;
  12. Females who are pregnant or breastfeeding;
  13. Participation in any other clinical trial within the past 1 months before screening and follow-up;
  14. The patient or the patient's legally authorized representative hasn't signed and dated an informed consent form;
  15. Other factors that would cause harm or increased risk to the participant or close contacts, or preclude the participant's full adherence as per investigator's judgement.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: group A
subjects applying the stent retriever(TonbridgeMT)
Enhed: stent retriever(TonbridgeMT)
mechanical thrombectomy with stent retriever(TonbridgeMT), digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging (MRI), diffusion weighted imaging (DWI)
Aktiv komparator: group B
subjects applying Solitaire™
Enhed: Solitaire™
mechanical thrombectomy with Solitaire™ , digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging(MRI), diffusion weighted imaging(DWI)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
successful recanalization rate in patients
Tidsramme: intraoperative immediate
Successful recanalization is defined as modified Thrombolysis In Cerebral Ischemia scale 2b or 3. And it is evaluated by DSA intraoperative immediately in both treatment groups
intraoperative immediate

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
successful recanalization rate in vessels
Tidsramme: intraoperative immediate
The proportion of successful recanalized vessels in all targeted vessels which receive the stent retriever treatment
intraoperative immediate
Time to achieve recanalization
Tidsramme: intraoperative immediate
The period from femoral artery puncture to successful recanalization
intraoperative immediate
NIHSS score
Tidsramme: baseline, 24±6d and 7±2d after operation
National Institutes of Health Stroke Scale
baseline, 24±6d and 7±2d after operation
mRS score
Tidsramme: baseline, 90±14d after operation
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
baseline, 90±14d after operation
the ratio of mRS 0-2
Tidsramme: baseline, 90±14d after operation
The proportion of patients who got a mRS 0-2 in patients who receive stent retriever treatment
baseline, 90±14d after operation
transportation performance
Tidsramme: intraoperative immediate
The proportion of stent retriever which can push and draw back well during the operation. The operator will grade each stent retriever at four level, namely great， good， average，and bad
intraoperative immediate

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Zhuhai Tonbridge Medical Tech. Co., Ltd.

Samarbejdspartnere

Guangzhou Osmunda Medical Device Technology, Inc., Ltd.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. august 2017

Primær færdiggørelse (Faktiske)

27. august 2018

Studieafslutning (Faktiske)

27. august 2018

Datoer for studieregistrering

Først indsendt

2. juli 2017

Først indsendt, der opfyldte QC-kriterier

4. juli 2017

Først opslået (Faktiske)

7. juli 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2018

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • JCQ-B-010

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med stent retriever(TonbridgeMT)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Gabon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner