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WILLIS covered stent for intracerebral ICA aneurysm at ophthalmic segment: a single-centered, prospective, observational registry study of safety and efficacy

WILLIS covered stent for intracerebral ICA aneurysm at ophthalmic segment: a single-centered, prospective, observational registry study of safety and efficacy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OOC-17011546
Enrollment
Unknown
Registered
2017-06-02
Start date
2017-07-01
Completion date
Unknown
Last updated
2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intracerebral aneurysm

Interventions

Sponsors

Beijing Neurosurgical Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Ophthalmic segment aneurysms diagnosed by MRA, CTA or DSA. The aneurysms include both ruptured (the interval between treatment and SAH should be more than 3 weeks) and unruptured, aneurysms treated for the first time or recurrent aneurysms. The shape of the aneurysms can be saccular, fusiform, blood-blister-like, and pseudo-aneurysm; 2. The patient ages between 18 and 75 years old; 3. Target vessel diameter ranges from 3.5-4.5mm; 4. The general state of the patients are suitable for treatment with intracranial deployment of a Willis covered stent through intravascular route; 5. Subject has provided written informed consent and is willing to participate the trial and comply with the required follow up.

Exclusion criteria

Exclusion criteria: 1) The target aneurysm is adjacent to important branches from the internal carotid artery like the anterior choroidal artery, the posterior communicating artery and ophthalmic artery. Whats more, the branch has no sufficient blood supply from other collaterals as confirmed by clinical imaging; 2) There is no appropriate endovascular route to access the aneurysms through a tortuous vessel; 3) Acutely ruptured aneurysms (SAH within 3 weeks) and patients with extra-ventricular drainage; 4) Patients with severe systematic disease or the general state is too weak for endovascular treatment. Those conditions including bleeding disorders, dysfunction of the heart, liver and renal. Patients with systematic infection and pregnant woman should be excluded; 5) The life expectancy of the patient is less than one year; 6) The patients has known contradictions to heparin, aspirin, clopidogrel, general anesthesia, fluoroscopic agent and X-ray; 7) Unstable neurological state and mental deficits, unable to comply with trial and to report adverse effect of the treatment.

Design outcomes

Primary

MeasureTime frame
complete occlusion rate of aneurysm;

Secondary

MeasureTime frame
procedural safety;stenosis degree of parent artery;clinical prognosis;Incidence of device-related adverse events;cerebrovascular event ratte;

Countries

China

Contacts

Public ContactChuhan Jiang

Beijing Neurosurgical Institute d Beijing Tiantan Hospital, Capital Medical University

jiangchuhan126@126.com+86 13911297825

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026