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

Huashan Hospital523 enrolled

Overview

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.

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

523

Conditions

Flow Diverter

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Huashan hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Aneurysm complete occlusion rate 12 months after surgery

Time frame: 12 months after surgery

Secondary Outcomes

Aneurysm complete occlusion rate 6 months after surgery

Time frame: 6 months after surgery

Immediate success rate

Time frame: Immediate

In-stent stenosis (>50% stenosis) rate 6,12 months after surgery

Time frame: 6,12 months after surgery

Incidence of ipsilateral disabled stroke 3 months after surgery, 6 months after surgery, and 12 months after surgery

Time frame: 3 months after surgery, 6 months after surgery, and 12 months after surgery

neurogenic death rate 6 months and 12 months after surgery

Time frame: 6 months and 12 months after surgery

Target aneurysm recurrence retreatment rate 6 months and 12 months after surgery

Time frame: 6 months and 12 months after surgery

Proportion of study participants with mRS score 0-2

Time frame: 3 months after surgery, 6 months after surgery, and 12 months after surgery

Incidence of adverse events (AE) and severe adverse events (SAE)

Time frame: 3 months after surgery, 6 months after surgery, and 12 months after surgery

Central Contacts

Gao Chao, PhD

CONTACT

18916960799 gc_huashanneuro@sina.com

Data from ClinicalTrials.gov

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