Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke(AIS)
10 september 2018 uppdaterad av: 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™.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
220
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
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
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Shanghai, Shanghai, Kina
- Changhai Hospital of Shanghai
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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)
|
|
Aktiv komparator: group B
subjects applying Solitaire™
|
mechanical thrombectomy with Solitaire™ , digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging(MRI), diffusion weighted imaging(DWI)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
successful recanalization rate in patients
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
successful recanalization rate in vessels
Tidsram: intraoperative immediate
|
The proportion of successful recanalized vessels in all targeted vessels which receive the stent retriever treatment
|
intraoperative immediate
|
|
Time to achieve recanalization
Tidsram: intraoperative immediate
|
The period from femoral artery puncture to successful recanalization
|
intraoperative immediate
|
|
NIHSS score
Tidsram: baseline, 24±6d and 7±2d after operation
|
National Institutes of Health Stroke Scale
|
baseline, 24±6d and 7±2d after operation
|
|
mRS score
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
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Samarbetspartners
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
3 augusti 2017
Primärt slutförande (Faktisk)
27 augusti 2018
Avslutad studie (Faktisk)
27 augusti 2018
Studieregistreringsdatum
Först inskickad
2 juli 2017
Först inskickad som uppfyllde QC-kriterierna
4 juli 2017
Första postat (Faktisk)
7 juli 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 september 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 september 2018
Senast verifierad
1 juni 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- JCQ-B-010
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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