Intracranial Aneurysm
Conditions
Brief summary
Intracranial aneurysm, as a common cerebrovascular disease, has a variety of treatment methods, including surgical treatment and endovascular treatment. Among these treatment methods, flow diverters have attracted much attention due to their unique therapeutic principles. Flow diverters help promote thrombus formation within the aneurysm by altering the direction and dynamics of blood flow, thereby achieving the purpose of treatment. 1-5 Flow diverters such as the Pipeline™ device have been proven to be safe and effective for the treatment of intracranial aneurysms and have gradually been recognized as the preferred device for the management of intracranial aneurysms.
Interventions
DEVICENovel Flow Diverter Stent
Patients with intracranial wide-neck aneurysms undergo implantation of new generation flow diverter stents (e.g., Pipeline Shield, Lattice, etc.) per IFU and local practice. Stent reconstructs parent artery, diverts flow, promoting aneurysm thrombosis. Concomitant antiplatelet therapy (DAPT: aspirin + clopidogrel/ticagrelor) given per guidelines, continued ≥3-6 months post-procedure. This is a prospective, multicenter, single-arm, real-world study in China (≈15 sites, N=280). Follow-up: 30d, 6m, 1y, then annually to 4y post-procedure, including clinical (mRS) and imaging (DSA/CTA) assessments.
Sponsors
Beijing Tiantan Hospital
Huashan Hospital
Peking University International Hospital
Beijing Chao Yang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent form and agreement to comply with protocol requirements. Age 22 to 80 years. Diagnosed with intracranial wide-neck aneurysm and planned for treatment with a flow diverter stent. Parent artery distal/proximal diameter compatible with available sizes and models of flow diverter stents, and treatment to be performed in accordance with the China NMPA-approved indications and instructions for use.
Exclusion criteria
* Need for treatment of another aneurysm in the affected territory of the target aneurysm using a different therapeutic modality during the study period. Prior intracranial implant (e.g., coils) in the target intracranial aneurysm territory within 6 months before enrollment. Prior surgery, including endovascular treatment, within 30 days before enrollment. Modified Rankin Scale (mRS) score ≥ 3. Any known contraindication to flow diverter stent treatment or antiplatelet therapy, including contraindications to dual antiplatelet therapy (DAPT). Pre-existing stent/flow diverter placed in the parent artery of the target aneurysm location. Investigator judges that the patient's health or the validity of study results (e.g., high risk of neurological events, conditions that may increase the chance of stroke) could be compromised by study participation. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period. Known allergy to platinum or cobalt-chromium alloys (including major elements: platinum, cobalt, chromium, nickel, or molybdenum).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aneurysm Complete Occlusion Rate | 1 year post-procedure | Proportion of patients with complete occlusion of the target aneurysm at 1 year post-procedure, as assessed by the core imaging laboratory using the Raymond-Roy Occlusion Classification (Class I: complete obliteration). |
Countries
China
Contacts
CONTACTHengwei Jin
Outcome results
None listed