Clinical Safety and Efficacy of Flow-diverter in the Treatment of Intracranial Aneurysms

Clinical Safety and Efficacy of Flow Diverter in the Treatment of Intracranial Aneurysms

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.

Study Overview

• Status: Recruiting
• Conditions: Flow Diverter

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.

• Study Type: Observational
• Enrollment (Estimated): 523

Contacts and Locations

• Study Contact: Name: Gao Chao, PhD; Phone Number: 18916960799; Email: gc_huashanneuro@sina.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Huashan Hospital
      • Contact: Gao Chao; Phone Number: +86 18916960799; Email: gc_huashanneuro@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Aneurysm complete occlusion rate 12 months after surgery	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Aneurysm complete occlusion rate 6 months after surgery	6 months after surgery
Immediate success rate	Immediate
In-stent stenosis (>50% stenosis) rate 6,12 months after surgery	6,12 months after surgery
Incidence of ipsilateral disabled stroke 3 months after surgery, 6 months after surgery, and 12 months after surgery	3 months after surgery, 6 months after surgery, and 12 months after surgery
neurogenic death rate 6 months and 12 months after surgery	6 months and 12 months after surgery
Target aneurysm recurrence retreatment rate 6 months and 12 months after surgery	6 months and 12 months after surgery
Proportion of study participants with mRS score 0-2	3 months after surgery, 6 months after surgery, and 12 months after surgery
Incidence of adverse events (AE) and severe adverse events (SAE)	3 months after surgery, 6 months after surgery, and 12 months after surgery

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Collaborators: Peking University First Hospital; Shanghai Zhongshan Hospital; The Second Hospital of Hebei Medical University; RenJi Hospital; Hebei General Hospital; First Affiliated Hospital Xi'an Jiaotong University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Xinqiao Hospital of Chongqing; Second Affiliated Hospital of Xi'an Jiaotong University; Xingtai People's Hospital; Second Affiliated Hospital of Nanchang University; Ningbo No.2 Hospital; Yichang Central People's Hospital; The Second Affiliated Hospital of Kunming Medical University; Suzhou Municipal Hospital; The First People's Hospital of Changzhou; Jiangxi Provincial People's Hopital; Jiangsu Taizhou People's Hospital; Huadong Hospital; Shanghai Pudong New Area People's Hospital; Tangshan Gongren Hospital; Eighth Affiliated Hospital, Sun Yat-sen University; Jingzhou Central Hospital; Zhengzhou Central Hospital; Xianning Central Hospital; The First People's Hospital of Changde City; Second People's Hospital of Hunan; Xuchang Central Hospital; Shanghai East Hospital of Tongji University; Shanghai Fourth People's Hospital; Northern Jiangsu People's Hospital; People's Hospital Of Ningxiang City; HUANG GANG Central Hospital; Shanghai Donglei Brain Hospital; THE AFFILIATED SUZHOU HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL
• Investigators: Study Chair: Gu Yuxiang, PhD, department of Neurosurgery, Huashan Hospital,Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Intracranial Aneurysm; Flow Diverter
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: KY2025-698

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No