- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03210623
Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke(AIS)
The Efficacy and Safety Study of Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Beijing, Cina
- The 306th Hospital of Chinese PLA
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Changchun, Cina
- the First Hospital of Jilin University
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Changchun, Cina
- China-Japan Union Hospital
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Changzhou, Cina
- The First People's Hospital of Changzhou
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Guangzhou, Cina
- The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
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Guiyang, Cina
- The Affiliated Hospital of Guizhou Medical University
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Hangzhou, Cina
- Hangzhou First People's Hospital
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Hanzhou, Cina
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Nanjing, Cina
- Nanjing First Hospital Affiliated to Nanjing Medicine University
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Nanning, Cina
- Nanning People's Hospital
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Wuhan, Cina
- The Third People's Hospital of Hubei Province
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Xi'an, Cina
- Tangdu Hospital
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Zhengzhou, Cina
- Henan Provincial People's Hospital
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Zhengzhou, Cina
- The First Affiliated Hospital of Zhengzhou University
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Zhongshan, Cina
- Zhongshan People's Hospital
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Zhuhai, Cina
- The Fifth Affiliated Hospital Sun Yat-Sen University
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Shanghai
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Shanghai, Shanghai, Cina
- Changhai Hospital of Shanghai
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 18≤ages≤80;
- Baseline NIHSS score obtained prior to randomization must be lower than 30 points;
- 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);
- 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;
- Pre-AIS mRS score lower than 2.
Exclusion Criteria:
- 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);
- DSA evidence of simultaneous acute bilateral carotid occlusion;
- DSA evidence of occlusions in the initial segment of carotid artery or carotid artery dissection or arteritis;
- DSA evidence of tortuosity of cervical vessels precluding device delivery/deployment;
- Hypertension (Systolic blood pressure(SBP)>185 mm Hg or diastolic blood pressure(DBP)>110 mm Hg) after using drug;
- Platelet count<40,000/μL and use of Novel Anticoagulant with International Normalized Ratio(INR)>3.0;
- Random blood glucose of<2.7mmol/L or>22.2mmol/L;
- 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);
- Patients who will not cooperate or tolerate interventional operation;
- Anticipated life expectancy of less than 90 days;
- Allergy to contrast medium;
- Females who are pregnant or breastfeeding;
- Participation in any other clinical trial within the past 1 months before screening and follow-up;
- The patient or the patient's legally authorized representative hasn't signed and dated an informed consent form;
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: group A
subjects applying the stent retriever(TonbridgeMT)
|
mechanical thrombectomy with stent retriever(TonbridgeMT), digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging (MRI), diffusion weighted imaging (DWI)
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Comparatore attivo: group B
subjects applying Solitaire™
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mechanical thrombectomy with Solitaire™ , digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging(MRI), diffusion weighted imaging(DWI)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
successful recanalization rate in patients
Lasso di tempo: 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
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intraoperative immediate
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
successful recanalization rate in vessels
Lasso di tempo: intraoperative immediate
|
The proportion of successful recanalized vessels in all targeted vessels which receive the stent retriever treatment
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intraoperative immediate
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Time to achieve recanalization
Lasso di tempo: intraoperative immediate
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The period from femoral artery puncture to successful recanalization
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intraoperative immediate
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NIHSS score
Lasso di tempo: baseline, 24±6d and 7±2d after operation
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National Institutes of Health Stroke Scale
|
baseline, 24±6d and 7±2d after operation
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mRS score
Lasso di tempo: baseline, 90±14d after operation
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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.
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baseline, 90±14d after operation
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the ratio of mRS 0-2
Lasso di tempo: baseline, 90±14d after operation
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The proportion of patients who got a mRS 0-2 in patients who receive stent retriever treatment
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baseline, 90±14d after operation
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transportation performance
Lasso di tempo: intraoperative immediate
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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
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intraoperative immediate
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Collaboratori e investigatori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- JCQ-B-010
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su stent retriever(TonbridgeMT)
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Hopital FochCompletato
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