Clinical trial NCT05524285: Safety Study of Intracranial Support Catheter and Guide Catheter for Stent-Assisted Embolization in the Treatment of Intracranial Aneurysms
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Aneurysm
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of symptomatic cerebral infarction within 48 hours postoperation
timeFrame: within 48 hours postoperation
Secondary outcomes:
measure: Incidence of new-onset DWI positive postoperation
timeFrame: within 48 hours postoperation
measure: Rate of catheter-related complications
timeFrame: Intraoperation
measure: Incidence of symptomatic cerebral infarction at 7 days postoperation or at discharge
timeFrame: 7 days postoperation or discharged
measure: Rate of mRS score 0-2 at 90 days
timeFrame: 90±14 days postoperation
measure: All-cause mortality within 90 days
timeFrame: up to 90 days
measure: Incidence of Adverse Events (AE)
timeFrame: up to 90 days
measure: Incidence of Serious Adverse Events (SAE)
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Huzhou
country: China
facility: Huzhou Central Hospital
state: Zhejiang
city: Lishui
country: China
facility: Lishui Municipal Central Hospital
state: Zhejiang
city: Lishui
country: China
facility: Lishui People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
state: Zhejiang
city: Shaoxing
country: China
facility: Shaoxing People's Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jing Xu
role: PRINCIPAL_INVESTIGATOR
References: