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: 1

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 (1)

• Success aneurysm occlusion at 6 month post procedure

  The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of flow diverter treated cerebral aneurysms (class I: complete obliteration, class II: residual neck, class III: residual aneurysm). Higher class represent a worse outcome. The percentage of Success aneurysm occlusion in which class 1 or 2 is achieved on the Raymond Scale at the 6 months follow-up angiographic assessments will be evaluated.

  6 months post procedure

Secondary Outcomes (12)

• Technical success

  Intra-procedure

• Success aneurysm occlusion immediately after the procedure

  Immediately after the procedure

• Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 6 months post procedure

  6 months post procedure

• Complete aneurysm occlusion at 6 months post procedure

  6 months post procedure

• Retreatment Rate at 6 months and 1 year post procedure

  6 months, 1 year 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 (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, 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: March 17, 2026

Record last verified: 2026-03

Locations

CN (1)