A Multicenter Prospective Study of New Flow Diverter Stent on the Treatment of Intracranial Aneurysms in China

NCT07821957 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Tiantan Hospital

Phase

Not applicable

Started

2026-01-06

Last updated

2026-09-16

Condition(s) studied

Intracranial Aneurysm

Investigational drug(s) / intervention(s)

Novel Flow Diverter Stent

Novel 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.

Study 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.

Eligibility

Sex

ALL

Min age

22 Years

Max age

80 Years

Healthy volunteers

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).

Primary outcome measure(s)

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).

Trial sites (1)

Facility	City	Region	Status
Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07821957 on ClinicalTrials.gov ↗ ← All trials in China