Intracranial AneurysmSAFETINCT05524285
Safety Study of Intracranial Support Catheter and Guide Catheter for Stent-Assisted Embolization in the Treatment of Intracranial Aneurysms
A study testing Intracranial Support Catheter and Guide Catheter in people with Intracranial Aneurysm, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Intracranial Support Catheter and Guide Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 9 sitesChina
- Study dates
- Feb 2023to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 16Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Jing Xu
- Not yet recruiting
Huzhou Central Hospital
Huzhou, Zhejiang
Sheng Qiu
- Not yet recruiting
Lishui Municipal Central Hospital
Lishui, Zhejiang
Shike He
- Not yet recruiting
Lishui People's Hospital
Lishui, Zhejiang
Huguang Li
- Not yet recruiting
Ningbo First Hospital
Ningbo, Zhejiang
Zhiqing Lin
- Not yet recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang
Maosong Chen
- Not yet recruiting
Shaoxing People's Hospital
Shaoxing, Zhejiang
Xuebin Yu
- Not yet recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
Shanping Ruan
- Not yet recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Bo Yin
About this study
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
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.
Read the 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.
- Conditions
- Intracranial Aneurysm
- Being tested
- Intracranial Support Catheter, Guide Catheter
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracranial Support CatheterDevice
Endovascular procedure using the intracranial support catheter which approved by NMPA
Guide CatheterDevice
Endovascular procedure using the guide catheter which approved by NMPA
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Intracranial Support Catheter Receives: Device: Intracranial Support Catheter |
| control group | Active comparator | Guide Catheter Receives: Device: Guide Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic cerebral infarction 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.
Measured: within 48 hours postoperation
Secondary outcomes (7)
Incidence of new-onset DWI positive postoperation
New-onset DWI positive is defined as any new hyperintense lesions.
Measured: within 48 hours postoperation
Rate of catheter-related complications
Catheter-related complications are defined as vasospasm, vascular dissection, etc. which caused by catheter during operation.
Measured: Intraoperation
Incidence of symptomatic cerebral infarction at 7 days postoperation or at discharge
Symptomatic cerebral infarction is defined as NIHSS score increased by≥4 points compared with preoperation, along with imaging confirmed to be caused by infarction.
Measured: 7 days postoperation or discharged
Rate of mRS score 0-2 at 90 days
mRS score 0-2 indicates good prognosis.
Measured: 90±14 days postoperation
All-cause mortality within 90 days
All-cause mortality is defined as all deaths due to any cause.
Measured: up to 90 days
Incidence of Adverse Events (AE)
Measured: up to 90 days
Incidence of Serious Adverse Events (SAE)
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study startFeb 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Xu, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524285
- Sponsor's protocol ID
- Study 2022-0505
- Acronym
- SAFETI
- Status last verified
- Aug 2022
- First submitted
- 30 Aug 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05524285
- Acronym / sponsor ID
- SAFETI / Study 2022-0505
- Conditions
- Intracranial Aneurysm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: Intracranial Support CatheterIntracranial Support Catheter |
| control group | Active comparator | Device: Guide CatheterGuide Catheter |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (16 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracranial Support CatheterEndovascular procedure using the intracranial support catheter which approved by NMPA | Device | experimental group |
| Guide CatheterEndovascular procedure using the guide catheter which approved by NMPA | Device | control group |
Primary outcome
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.
7 secondary outcomes
Incidence of new-onset DWI positive postoperation
Time frame: within 48 hours postoperation
Rate of catheter-related complications
Time frame: Intraoperation
Incidence of symptomatic cerebral infarction at 7 days postoperation or at discharge
Time frame: 7 days postoperation or discharged
Rate of mRS score 0-2 at 90 days
Time frame: 90±14 days postoperation
All-cause mortality within 90 days
Time frame: up to 90 days
Incidence of Adverse Events (AE)
Time frame: up to 90 days
Incidence of Serious Adverse Events (SAE)
Time frame: up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
Related trials for Intracranial Aneurysm
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Xu principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracranial Support Catheter and Guide Catheter in people with Intracranial Aneurysm, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Xu (13958119687, jingxu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of symptomatic cerebral infarction within 48 hours postoperation (time frame: within 48 hours postoperation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.