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Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations

4. maj 2022 opdateret af: Suzhou Hengruihongyuan Medical Technology Co. LTD

A Prospective, Multi-center, Randomized Parallel Controlled Study on the Safety and Effectiveness of the Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations

This clinical trial is to verify the safety and effectiveness of the Non-adhesive Liquid Embolic System(NALES) produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. in the process of clinical use to support the application of the National Medical Products Administration ( NMPA) product registration approval.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A prospective, multicenter, randomized controlled trial was used in this study. Onyx Liquid Embolic System and Marathon Flow Directed Micro Catheter, which were registered and marketed in China and had good effect in the industry, were selected as the control devices. Subjects requiring cerebral arteriovenous malformation embolization were selected to participate in the trial based on pathological conditions and inclusion/exclusion criteria, and the use of test products or control products was determined based on central randomized results. Imaging data involving the main evaluation criteria were evaluated uniformly by the blind evaluators of the leading unit, so as to reduce the bias caused by subjective factors of different evaluators.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

116

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • Ikke rekrutterer endnu
        • Guangdong Provincial People's Hospital
        • Kontakt:
          • Dong Zhou
      • Guangzhou, Guangdong, Kina, 510280
        • Ikke rekrutterer endnu
        • Zhujiang Hospital of Southern Medical University
        • Kontakt:
          • Chuanzhi Duan
      • Guangzhou, Guangdong, Kina, 510515
        • Ikke rekrutterer endnu
        • Nan Fang Hospital
        • Kontakt:
          • Songtao Qi
    • Heilongjiang
      • Harbin, Heilongjiang, Kina
        • Ikke rekrutterer endnu
        • The First Affiliated Hospital of Harbin Medical University
        • Kontakt:
          • Huaizhang Shi
    • Henan
      • Zhengzhou, Henan, Kina
        • Rekruttering
        • Henan Provincial People's Hospital
        • Kontakt:
          • Tianxiao Li
    • Hubei
      • Wuhan, Hubei, Kina, 430071
        • Ikke rekrutterer endnu
        • Zhongnan Hospital of Wuhan University
        • Kontakt:
          • Jincao Chen
    • Jiangsu
      • Changzhou, Jiangsu, Kina
        • Ikke rekrutterer endnu
        • The First People's Hospital of Changzhou
      • Nanjing, Jiangsu, Kina, 210008
        • Ikke rekrutterer endnu
        • Nanjng Drum Tower Hospital
        • Kontakt:
          • Chunhua Hang
      • Nanjing, Jiangsu, Kina
        • Ikke rekrutterer endnu
        • General Hospital of Eastern Theater Command
        • Kontakt:
          • HanDong Wang
    • Jiangxi
      • Nanchang, Jiangxi, Kina
        • Ikke rekrutterer endnu
        • The Second Affiliated Hospital of Nanchang University
        • Kontakt:
          • Xingen Zhu
    • Shanghai
      • Shanghai, Shanghai, Kina
        • Rekruttering
        • Shanghai Changhai Hospital
        • Kontakt:
          • Jianmin Liu, Doctor
      • Shanghai, Shanghai, Kina
        • Ikke rekrutterer endnu
        • Huashan Hospital ,Fudan University
        • Kontakt:
          • Yuxiang Gu, Doctor
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 322000
        • Ikke rekrutterer endnu
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Kontakt:
          • Jianmin Zhang

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 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age 18-70 years old, no gender limit.
  2. The patient was diagnosed as cerebral arteriovenous malformation .
  3. The patient had no history of bAVM treatment, including intervention, surgery or radiotherapy .
  4. Spetzler Martin, grade I-IV .
  5. The patient voluntarily signed the informed consent.

Exclusion Criteria:

  1. History of heparin allergy.
  2. The patient is allergic to contrast media.
  3. Severe hepatic and renal insufficiency (serum creatinine ≥1.5 times the upper limit of normal value, alanine aminotransferase ≥3 times the upper limit of normal value, aspartate aminotransferase ≥3 times the upper limit of normal value).
  4. Patient has irreversible coagulopathy (INR > 1.5).
  5. Intracranial hemorrhage 1 week before treatment.
  6. MRS ≥4 due to neurological dysfunction.
  7. Patients with planned malformation resection after embolization.
  8. Blood flow related aneurysms of supplying artery that need to be treated by other methods.
  9. Complicated with severe cerebral artery stenosis.
  10. Brain tumors that require recent surgery.
  11. Complicated with proliferative cerebrovascular disease.
  12. Pregnant or lactating women.
  13. Participants who have participated in other clinical trials within the last 3 months and failed to reach the end point.
  14. The number of embolism is expected to be greater than or equal to 4 times during the study period (within 1 year).
  15. Subjects deemed unsuitable for this study by the investigator.

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: Non-adhesive Liquid Embolic System(NALES)
Enhed: embolism
Cerebral arteriovenous malformation embolism
Aktiv komparator: Onyx Liquid Embolic System& Marathon Flow Directed Micro Catheter
Enhed: embolism
Cerebral arteriovenous malformation embolism

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effective embolization rate of malformed masses
Tidsramme: Immediately after surgery
Number of effective embolization subjects / Total number of subjects x 100%.Definition of effective embolization : Postoperative DSA angiographic malformation volume decreased ≥50%. Volume of malformed groups = length × width × height /2.
Immediately after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
MRS score
Tidsramme: 1,6,12months after surgery
MRS refers to the modified Rankin scale, which is used to measure the neurological recovery of patients after stroke. It has a scale of zero to six. The higher the score, the worse the neurological function. MRS scores were collected at 1, 6 and 12 months after the operation before discharge .
1,6,12months after surgery
Technical success rate
Tidsramme: Immediately after surgery
Success is represented by the ability to reach the lesion and embolize the malformed mass of the intended target, followed by successful catheter withdrawal from the body
Immediately after surgery
Catheter performance evaluation
Tidsramme: Immediately after surgery
  1. The ability of the catheter to reach the lesion .
  2. The catheter has broken at the tip and perforated.
  3. Intravascular complications associated with catheters occurred.
  4. Degree of difficulty in tube withdrawal
  5. Catheter jam
Immediately after surgery

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of major adverse events related to device or surgical procedures within 1 month after surgery
Tidsramme: 1 month after surgery
Major adverse events related to instrumentation or surgical procedures within 1 month after surgery: bleeding during embolization, catheter indwelling, bleeding after embolization, symptomatic cerebral infarction, and edema.
1 month after surgery

Samarbejdspartnere og efterforskere

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

Sponsor

Suzhou Hengruihongyuan Medical Technology Co. LTD

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)

2. december 2021

Primær færdiggørelse (Forventet)

17. oktober 2023

Studieafslutning (Forventet)

17. oktober 2024

Datoer for studieregistrering

Først indsendt

24. september 2021

Først indsendt, der opfyldte QC-kriterier

24. september 2021

Først opslået (Faktiske)

27. september 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2022

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Nal01

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

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 .

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