Clinical trial NCT06943729: Clinical Safety and Efficacy of Flow-diverter in the Treatment of Intracranial Aneurysms
Official title: Clinical Safety and Efficacy of Flow Diverter in the Treatment of Intracranial Aneurysms
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Flow Diverter
Keywords: Flow Diverter
Intracranial Aneurysm
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Xinqiao Hospital of Chongqing
name: Ningbo No.2 Hospital
name: Eighth Affiliated Hospital, Sun Yat-sen University
name: Second Affiliated Hospital of Nanchang University
name: Jiangxi Provincial People's Hopital
name: Zhengzhou Central Hospital
name: Xuchang Central Hospital
name: Second People's Hospital of Hunan
name: People's Hospital Of Ningxiang City
name: The First People's Hospital of Changde City
name: HUANG GANG Central Hospital
name: Xianning Central Hospital
name: Jingzhou Central Hospital
name: Yichang Central People's Hospital
name: The First People's Hospital of Changzhou
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Northern Jiangsu People's Hospital
name: Suzhou Municipal Hospital
name: Jiangsu Taizhou People's Hospital
name: Huadong Hospital
name: RenJi Hospital
name: Shanghai Zhongshan Hospital
name: Shanghai Fourth People's Hospital
name: Shanghai Donglei Brain Hospital
name: Shanghai Pudong New Area People's Hospital
name: Shanghai East Hospital of Tongji University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Second Affiliated Hospital of Xi'an Jiaotong University
name: Tangshan Gongren Hospital
name: The Second Hospital of Hebei Medical University
name: Hebei General Hospital
name: Xingtai People's Hospital
name: Peking University First Hospital
name: THE AFFILIATED SUZHOU HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL
name: The Second Affiliated Hospital of Kunming Medical University
First posted: 2025-04-24
Enrollment: 523
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: intracranial aneurysm diagnosed by CTA, MRA or DSA (Including wide-necked aneurysms (neck width ≥4mm or Dome/neck ratio \<2), saccular, fusiform aneurysms, recurrent saccular aneurysms and dissecting aneurysms, and the diameter of the parent vessel ≥ 2.0 mm and ≤ 6.0 mm

Brief summary: To collect the safety and effectiveness data of flow-di in the treatment of intracranial aneurysms in real-world clinical practice, verify its classification of treatment strategies for aneurysms of different locations and shapes, and optimize postoperative medication regimen, provide long-term evidence-based basis for clinical treatment of intracranial aneurysms, and build a database.

Detailed description: The purpose of this study is to verify the clinical safety and effectiveness of Flow Diverters (FD) in the treatment of intracranial aneurysms. In recent years, FD, as a new type of minimally invasive interventional treatment method, has been widely used in the treatment of various types of intracranial aneurysms. FD promotes the formation of thrombosis in the aneurysm by changing the hemodynamics of the aneurysm, and promotes the repair of vascular endothelium, thereby achieving tumor occlusion. In this study, 523 patients with various types of intracranial aneurysms will be recruited in 36 centers, using a multicenter, prospective, single-arm study design. The main goal of the study was to assess the complete occlusion rate of aneurysms in the 12 months after FD treatment. Secondary goals included postoperative complications (such as cerebral infarction, intracranial thrombosis), postoperative nerve function recovery, and patients' quality of life. At the same time, a large-scale domestic FD database for the treatment of intracranial aneurysms was established. The results of the study will verify the efficacy and safety of FD through clinical imaging evaluation (mainly cerebral angiography) and long-term clinical follow-up data. At the same time, the success rate of surgery and the incidence of restenosis in the stent are analyzed to comprehensively evaluate the application prospects of FD in the treatment of intracranial aneurysms. The results of this study will provide an important evidence-based basis for further promoting the clinical application of FD, optimizing the treatment plan of aneurysms, and improving the patient's prognosis.

Eligibility criteria: Inclusion Criteria:

1)18 years ≤80 years; 2) intracranial aneurysm diagnosed by CTA, MRA or DSA (Including wide-necked aneurysms (neck width ≥4mm or Dome/neck ratio \<2), saccular, fusiform aneurysms, recurrent saccular aneurysms and dissecting aneurysms, and the diameter of the parent vessel ≥ 2.0 mm and ≤ 6.0 mm; the location includes: anterior circulation C3 segment and above of internal carotid artery, distal artery of Willis circle, posterior circulation V4 segment of vertebral artery and basilar artery and its main branches; 3) Voluntary participation in this study and signing of the Informed Consent Form (ICF).

Exclusion Criteria:

1)AVM related aneurysm; 2) Acute ruptured aneurysm; 3) Severe stenosis or tortuosity of intracranial artery, or anatomical abnormality, which makes it difficult for the device to reach the lesion ; 4) Patients with hemorrhagic or ischemic stroke within 30 days; 5) Modified Rankin Score (mRS)\>2 points before operation; 6) Patients with life expectancy less than 12 months; 7) Patients with definite history of allergy to cobalt-chromium alloy and platinum-tungsten alloy materials; Allergy to contrast media; 8) antiplatelet (PLT)\<100×10\^ 9 /L or/and anticoagulation contraindicated; 9) pregnant or lactating women; 10) other study participants who were assessed by the investigator as unsuitable for participation in the study.

Intraoperative exclusion criteria: 1) acute rupture and hemorrhage of aneurysm during operation; 2) failure of FD implantation; 3) thrombosis in stent; 4) stent mal-apposition.

Primary outcomes:
measure: Aneurysm complete occlusion rate 12 months after surgery
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Aneurysm complete occlusion rate 6 months after surgery
timeFrame: 6 months after surgery
measure: Immediate success rate
timeFrame: Immediate
measure: In-stent stenosis (>50% stenosis) rate 6,12 months after surgery
timeFrame: 6,12 months after surgery
measure: Incidence of ipsilateral disabled stroke 3 months after surgery, 6 months after surgery, and 12 months after surgery
timeFrame: 3 months after surgery, 6 months after surgery, and 12 months after surgery
measure: neurogenic death rate 6 months and 12 months after surgery
timeFrame: 6 months and 12 months after surgery
measure: Target aneurysm recurrence retreatment rate 6 months and 12 months after surgery
timeFrame: 6 months and 12 months after surgery
measure: Proportion of study participants with mRS score 0-2
timeFrame: 3 months after surgery, 6 months after surgery, and 12 months after surgery
measure: Incidence of adverse events (AE) and severe adverse events (SAE)
timeFrame: 3 months after surgery, 6 months after surgery, and 12 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: department of Neurosurgery, Huashan Hospital,Fudan University
name: Gu Yuxiang, PhD
role: STUDY_CHAIR
References: