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Intracranial AneurysmNCT06303063

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

A study testing SINOMED IAS Stent System and Neuroform Atlas Stent System in people with Intracranial Aneurysm, run by Sinomed Neurovita Technology Inc. at 14 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Intracranial Aneurysm
What is being tested?
SINOMED IAS Stent System and Neuroform Atlas Stent System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
14 sitesChina
Study dates
17 Jan 2024to 20 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

China14 sites

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing

  • West China Hospital of Sichuan University

    Chengdu

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang

  • The First Affiliated Hospital of Harbin Medical University

    Harbin

  • The First Hospital of Jilin University

    Jilin City

  • Jinhua Central Hospital

    Jinhua

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • Affiliated Drum Tower Hospital, Medical School of Nanjing University

    Nanjing

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

    Nanjing

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

    Tangdu

  • The First Affiliated Hospital of Wannan Medical University

    Wuhu

  • The First Affiliated Hospital of Xinjiang Medical University

    Xinjiang

  • Henan Provincial People's Hospital

    Zhengzhou

  • Zhujiang Hospital of Southern Medical University

    Zhujiang

Other trials in China

About this study

Official title: A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Effectiveness of the SINOMED IAS for the Treatment of Intracranial Aneurysms

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

Read the detailed description

This study is a prospective, multicenter, 1:1 randomized clinical trial to evaluate the safety and efficacy of stent system in the treatment of intracranial aneurysms. A total of 204 patients are planned to be included. The primary efficacy endpoint is complete aneurysm occlusion without retreatment or significant parent artery stenosis at 12 months post-procedure. The primary safety endpoint is the incidence of major ipsilateral stroke or neurogenic death within 12 months post-procedure. All patients will have clinical follow-up during intraoperative, 30 days, 6 months, 1 year.

Being tested
SINOMED IAS Stent System, Neuroform Atlas Stent System
Keywords
wide-necked cerebral aneurysms, Brain Aneurysm, Cerebral Aneurysm, Stent
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SINOMED IAS Stent SystemDevice

    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 SystemDevice

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

Study groups in NCT06303063
Study groupRoleWhat they receive
SINOMED IAS Stent SystemExperimentalThe SINOMED IAS Stent System is intended for use with occlusive devices in the treatment of intracranial aneurysms.
Receives: Device: SINOMED IAS Stent System
Neuroform Atlas Stent SystemActive comparatorThe Neuroform Atlas Stent System is intended for use with occlusive devices in the treatment of intracranial aneurysms.
Receives: Device: Neuroform Atlas Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months post-procedure

  2. 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.

    Measured: 12 months post-procedure

Secondary outcomes (12)

  1. Technical success

    Technical success defined as stable stent placement with complete coverage across the aneurysm neck and parent artery patency.

    Measured: Intra-procedure

  2. Complete aneurysm occlusion or success aneurysm occlusion immediately after the procedure

    Complete occlusion defined as complete obliteration of the aneurysm sac, including the neck (grade I). Success aneurysm occlusion was as defined by grade I (complete obliteration) and II (residual neck).

    Measured: Immediately after the procedure

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

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

    Measured: 12 months post procedure

  4. Complete aneurysm occlusion or success aneurysm occlusion at 12 months post procedure

    Complete occlusion defined as complete obliteration of the aneurysm sac, including the neck (grade I). Success aneurysm occlusion was as defined by grade I (complete obliteration) and II (residual neck).

    Measured: 12 months post procedure

  5. Retreatment Rate at 6 months and 12 months post procedure

    The percentage of target aneurysms that are retreated at any time up to and including the 6 months and 12 months follow-up visit will be evaluated. Retreatment will be defined as any additional treatment of the target aneurysm after the index procedure (retreatment includes staged procedures), and (regardless of whether retreatment is by surgery or endovascular treatment) due to recanalization, rupture or bleeding.

    Measured: 6 months, 12 months post procedure

  6. In-Stent Stenosis at 12 months post procedure

    In-stent stenosis defined as greater than 50% narrowing of the vessel within the stent or within 5mm of either end of the stent.

    Measured: 12 months post procedure

  7. Modified Rankin Scale (mRS) at 30 days, 6 months and 12 months post procedure

    Observed scores on the Modified Rankin Scale will be presented at baseline (pre-procedure) and follow-up (30 days, 6 and 12 months post-procedure). The number and percentage of subjects who have an mRS ≤ 2 will be evaluated.

    Measured: 30 days, 6 months, 12 months post procedure

  8. Major ipsilateral stroke or neurogenic death at 30 days, 6 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.

    Measured: 30 days, 6 months post procedure

  9. All-cause mortality at 30 days, 6 months and 12 month post procedure

    Deaths due to any cause are calculated.

    Measured: 30 days, 180 days and 12 months post procedure

  10. Incidence of adverse events/serious adverse events during 30 days, 6 months and 12 month post procedure

    Percentage (%) of participants who experienced adverse events/serious adverse events.

    Measured: 30 days, 6 months and 12 months post procedure

  11. In-stent thrombosis at 12 months post procedure

    Stent thrombosis defined as a thrombotic occlusion of a stent.

    Measured: 12 months post procedure

  12. Rate of Device defect

    Device defects refer to the unreasonable risks that may endanger human health and life safety during the normal use of medical devices in the course of clinical trials, such as label errors, quality problems, failures, etc.

    Measured: within 12 months of whole trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start17 Jan 2024
  3. Primary completion20 Nov 2025
  4. Study completion20 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06303063
Sponsor's protocol ID
SNSC-IAS-202301
Status last verified
Jul 2026
First submitted
4 Mar 2024
Last updated
13 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing SINOMED IAS Stent System and Neuroform Atlas Stent System in people with Intracranial Aneurysm, run by Sinomed Neurovita Technology Inc. at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary efficacy endpoint is complete aneurysm occlusion without retreatment or significant parent artery stenosis at 12 months post-procedure (time frame: 12 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06303063.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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