Safety Study of Intracranial Support Catheter and Guide Catheter for Stent-Assisted Embolization in the Treatment of Intracranial Aneurysms
NCT ID: NCT05524285
Last Updated: 2023-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
264 participants
INTERVENTIONAL
2023-02-28
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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experimental group
Intracranial Support Catheter
Intracranial Support Catheter
Endovascular procedure using the intracranial support catheter which approved by NMPA
control group
Guide Catheter
Guide Catheter
Endovascular procedure using the guide catheter which approved by NMPA
Interventions
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Intracranial Support Catheter
Endovascular procedure using the intracranial support catheter which approved by NMPA
Guide Catheter
Endovascular procedure using the guide catheter which approved by NMPA
Eligibility Criteria
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Inclusion Criteria
* Preoperative modified Rankin Scale (mRS) score 0-2;
* Subject has an unruptured intracranial aneurysm in the anterior circulation diagnosed by DSA/CTA/MRA (accept the results from other hospital)；
* No intracranial hemorrhage and recent cerebral infarction (DWI indicates hyperintense lesions) are founded by preoperative MRI+DWI;
* Subject is assessed as suitable for stent-assisted coil embolization (SACE) treatment (except flow diverter stent);
* Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form.
Exclusion Criteria
* Subject with atrial fibrillation, patent foramen ovale, atrial septal defect, ventricular septal defect, and other diseases causing cardiogenic embolism;
* Inability to perform cranial MRI+DWI preoperatively and within 48 hours postoperatively;
* Hypertension that does not respond well to medical treatment (systolic blood pressure\>185 mmHg and/or diastolic blood pressure\>110 mmHg);
* Preoperative active bleeding or bleeding tendency (INR\>3);
* Random blood glucose\<2.7mmol/L or \>22.2mmol/L;
* Heart, lung, liver and kidney failure or other serious diseases (intracranial tumor, intracranial arteriovenous malformation, severe infection, DIC, previous myocardial infarction, history of severe psychosis, etc.);
* Subject who will not cooperate or tolerate interventional operation;
* Anticipated life expectancy\<1 year;
* Allergy, resistance or contraindication to one or more of the following: contrast agents, anesthetics, antiplatelet drugs, anticoagulants;
* Participated or participating in another drug or device clinical trial within 1 month prior to enrollment;
* Pregnant or breast-feeding woman;
* Other circumstances judged by researchers that are not suitable for enrollment;
* Catheter could not pass through due to obvious intracranial vessel stenosis or tortuosity determined from imaging;
* Multiple aneurysms and more than one aneurysm requiring treatment;
* The aneurysm body has arterial branches.
18 Years
70 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Jing Xu
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
Lishui Municipal Central Hospital
Lishui, Zhejiang, China
Lishui People's Hospital
Lishui, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
Shaoxing People's Hospital
Shaoxing, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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Study 2022-0505
Identifier Type: -
Identifier Source: org_study_id
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