Compare the Safety and Effectiveness of Two Different Kinds of Stent System in Intracranial Aneurysms

NCT06303063 | Completed

• 1 other identifier: SNSC-IAS-202301
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 14

Brief Summary

The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IAS in patients with intracranial aneurysms.

Conditions

Intracranial Aneurysm

Keywords

wide-necked cerebral aneurysms; Brain Aneurysm; Cerebral Aneurysm; Stent

Outcome Measures

Primary Outcomes (2)

• The primary efficacy endpoint is complete aneurysm occlusion without retreatment or significant parent artery stenosis at 12 months post-procedure

  Proportion of subjects with complete occlusion of the target aneurysm, ≤50% stenosis of the parent artery at the target cerebral aneurysms at 1 year as assessed by angiography, and in whom an unplanned alternative treatment of the target cerebral aneurysms had not been performed within 12 months.

  12 months post-procedure

• The primary safety endpoint is the incidence of major ipsilateral stroke or neurogenic death within 12 months post-procedure

  National Institute of Health Stroke Scale (NIHSS) was used to assess patients after stroke in an 11-item scale with potential scores ranging from 0 to 42. Higher values represent a worse outcome. A major stroke is defined as a new neurological event which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of ≥ 4 on the NIHSS as compared to baseline.

  12 months post-procedure

Secondary Outcomes (12)

• Technical success

  Intra-procedure

• Complete aneurysm occlusion or success aneurysm occlusion immediately after the procedure

  Immediately after the procedure

• Success aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 12 months post procedure

  12 months post procedure

• Complete aneurysm occlusion or success aneurysm occlusion at 12 months post procedure

  12 months post procedure

• Retreatment Rate at 6 months and 12 months post procedure

  6 months, 12 months post procedure

Study Arms (2)

SINOMED IAS Stent System

EXPERIMENTAL

The SINOMED IAS Stent System is intended for use with occlusive devices in the treatment of intracranial aneurysms.

Device: SINOMED IAS Stent System

Neuroform Atlas Stent System

ACTIVE COMPARATOR

The Neuroform Atlas Stent System is intended for use with occlusive devices in the treatment of intracranial aneurysms.

Device: Neuroform Atlas Stent System

Interventions

SINOMED IAS Stent System DEVICE

Stent-assisted coiling (SAC) of intracranial aneurysms paved the way for endovascular coiling of wide-neck aneurysms, improving rates of aneurysm obliteration and recurrence.

SINOMED IAS Stent System

Neuroform Atlas Stent System DEVICE

Stent-assisted coiling (SAC) of intracranial aneurysms paved the way for endovascular coiling of wide-neck aneurysms, improving rates of aneurysm obliteration and recurrence.

Neuroform Atlas Stent System

Eligibility Criteria

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

You may qualify if:

• Age 18 years to 80 years.
• Wide-necked (Wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio \< 2), saccular, intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2.5 mm and ≤ 5mm.
• Modified Rankin Scale (mRS) ≤ 2.
• Subject understands the nature of the procedure, provides voluntary written informed consent prior to the treatment, and is willing to comply with specified follow-up evaluation.
• The investigators judged the use of stent-assisted coil embolization to be appropriate for the treatment of intracranial aneurysm.

You may not qualify if:

• Target aneurysm is an aneurysm requiring staged procedure.
• Target aneurysm that has been previously treated with vascular embolization or surgery.
• Target aneurysms are fusiform aneurysms, dissecting aneurysms, pseudoaneurysms, blood blister-like aneurysms, infected aneurysms, aneurysms associated with arteriovenous malformations.
• Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery.
• Acutely ruptured aneurysm within 14 days of enrollment.
• Hunt and Hess (H\&H) scale ≥3.
• Subject who had Moyamoya disease, arteriovenous malformations, arteriovenous fistulae, intracranial tumors, or intracranial mass lated to target aneurysms.
• Severe stenosis or tortuosity of intracranial arteries or anatomical anomalies that make it difficult to reach the site of the lesion with device.
• Platelet count \<50\*103/mm3 (50\*109/L) or any known coagulation deficiency, or International normalized ratio (INR)\>3.0.
• Known hypersensitivity/allergies or contraindication to contrast media, stent components, antiplatelets, anticoagulants.
• Life expectancy \< 1 year, and unable to complete the required follow-ups;
• Female who was pregnant or breastfeeding, women/men planning to havve children in the next year.
• Currently enrolled in another investigational device or drug study.

Sponsors & Collaborators

• Sinomed Neurovita Technology Inc.: lead

Study Sites (14)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

Location

West China Hospital of Sichuan University

Chengdu, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, China

Location

The First Hospital of Jilin University

Jilin City, China

Location

Jinhua Central Hospital

Jinhua, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

Affiliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, China

Location

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)

Nanjing, China

Location

The Second Affiliated Hospital of the Air Force Medical University (Tangdu Hospital of Fourth Military Medical University)

Tangdu, China

Location

The First Affiliated Hospital of Wannan Medical University

Wuhu, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Xinjiang, China

Location

Henan Provincial People's Hospital

Zhengzhou, China

Location

Zhujiang Hospital of Southern Medical University

Zhujiang, China

Location

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

Study Officials

• xinJian Yang

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: January 17, 2024
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

CN (14)