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

NCT07821957 | Recruiting DMC

• 2 other identifiers: KY2025-190-032025-3098-YXZX-0483
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

• Aneurysm Complete Occlusion Rate

  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).

  1 year post-procedure

Study Arms (1)

Flow Diverter Stent Treatment Group

EXPERIMENTAL

Device: Novel Flow Diverter Stent

Interventions

Novel Flow Diverter Stent DEVICE

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.

Flow Diverter Stent Treatment Group

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Huashan Hospital: collaborator
• Peking University International Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (2)

• Aoki T, Nozaki K. Preemptive Medicine for Cerebral Aneurysms. Neurol Med Chir (Tokyo). 2016 Sep 15;56(9):552-68. doi: 10.2176/nmc.st.2016-0063. Epub 2016 Apr 6.

  PMID: 27053328 BACKGROUND

• Al-Mufti F, Amuluru K, Gandhi CD, Prestigiacomo CJ. Flow Diversion for Intracranial Aneurysm Management: A New Standard of Care. Neurotherapeutics. 2016 Jul;13(3):582-9. doi: 10.1007/s13311-016-0436-4.

  PMID: 27160270 BACKGROUND

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Hengwei Jin

CONTACT

15001189679; jinhengwei123@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start: January 6, 2026
• Primary Completion (Estimated): August 29, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)