NCT05524285UnknownNot Applicable
Safety Study of Intracranial Support Catheter and Guide Catheter for Stent-Assisted Embolization in the Treatment of Intracranial Aneurysms: A Prospective, Multicenter, Randomized, Open, Controlled, Superiority Trial
Second Affiliated Hospital, School of Medicine, Zhejiang University9 sites in 1 country264 target enrollmentStarted: February 1, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 264
- Locations
- 9
- Primary Endpoint
- Incidence of symptomatic cerebral infarction within 48 hours postoperation
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety differences between intracranial support catheter and guide catheter for stent-assisted embolization in the treatment of unruptured intracranial aneurysms in the anterior circulation.
Detailed Description
This is a prospective, multicenter, randomized, open, controlled, superiority trial carried out in 9 research centers over China. Patients are randomized 1:1 to therapy either intracranial support catheter or guide catheter. Taking the guide catheter as a control, to evaluate whether the safety of intracranial support catheter for stent-assisted embolization in the treatment of unruptured intracranial aneurysms in the anterior circulation is superior than that of the control.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age≥18 and≤70 years, any gender;
- •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
- •Inadequate antiplatelet therapy before surgery (more than 3 days);
- •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.
Arms & Interventions
experimental group
Experimental
Intracranial Support Catheter
Intervention: Intracranial Support Catheter (Device)
control group
Active Comparator
Guide Catheter
Intervention: Guide Catheter (Device)
Outcomes
Primary Outcomes
Incidence of symptomatic cerebral infarction within 48 hours postoperation
Time Frame: within 48 hours postoperation
Symptomatic cerebral infarction is defined as NIHSS score increased by≥4 points compared with preoperation, along with imaging confirmed to be caused by infarction.
Secondary Outcomes
- Incidence of Serious Adverse Events (SAE)(up to 90 days)
- Incidence of symptomatic cerebral infarction at 7 days postoperation or at discharge(7 days postoperation or discharged)
- Incidence of Adverse Events (AE)(up to 90 days)
- Incidence of new-onset DWI positive postoperation(within 48 hours postoperation)
- Rate of catheter-related complications(Intraoperation)
- Rate of mRS score 0-2 at 90 days(90±14 days postoperation)
- All-cause mortality within 90 days(up to 90 days)
Investigators
Study Sites (9)
Loading locations...
Similar Trials
Terminated
Not Applicable
Evaluation of the Safety and Clinical Performance of the Connected Catheter StudyChronicUrinary RetentionNCT05330598Spinal Singularity26
Recruiting
Not Applicable
The Efficacy and Safety of Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomatic Intracranial Atherosclerotic StenosisIntracranial AtherosclerosisNCT05757505Ton-Bridge Medical Tech. Co., Ltd200
Not yet recruiting
Not Applicable
The Efficacy and Safety of Intracranial Stent (Tonbridge) in Endovascular Treatment of Intracranial Atherosclerotic StenosisIntracranial AtherosclerosisNCT05593224Zhuhai Tonbridge Medical Tech. Co., Ltd.156
Completed
Not Applicable
Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy VolunteersSpinal Cord InjuryNCT01142115Coloplast A/S41
Completed
Not Applicable
Balloon Catheter vs. Basket Catheter in Pancreatic Duct Stone ClearanceChronic PancreatitisNCT05888012Changhai Hospital6,493