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

Not Applicable

Recruiting

• Conditions: Intracranial Aneurysm
• Interventions: Device: SINOMED IAS Stent System; Device: Neuroform Atlas Stent System

• Registration Number: NCT06303063
• Lead Sponsor: Sinomed Neurovita Technology Inc.

Brief Summary

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

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 endpoint is the incidence of success aneurysm occlusion at 6-month post procedure. All patients will have clinical follow-up during intraoperative, 30 days, 6 months, 1 year.

Study Timeline

• Study Start: 2024-01-17
• Status Verified: 2024-03
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-12
• Last Update Submitted: 2024-03-29
• Last Update Posted: 2024-04-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

1. Age 18 years to 80 years.
2. 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.
3. Modified Rankin Scale (mRS) ≤ 2.
4. 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.
5. The investigators judged the use of stent-assisted coil embolization to be appropriate for the treatment of intracranial aneurysm.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SINOMED IAS Stent System	SINOMED IAS Stent System	The SINOMED IAS Stent System is intended for use with occlusive devices in the treatment of intracranial aneurysms.
Neuroform Atlas Stent System	Neuroform Atlas Stent System	The Neuroform Atlas Stent System is intended for use with occlusive devices in the treatment of intracranial aneurysms.

Primary Outcome Measures

Name	Time	Method
Success aneurysm occlusion at 6 month post procedure	6 months 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.

Secondary Outcome Measures

Name	Time	Method
Retreatment Rate at 6 months and 1 year post procedure	6 months, 1 year post procedure	The percentage of target aneurysms that are retreated at any time up to and including the 6 months and 1 year 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.
Modified Rankin Scale (mRS) at 30 days, 6 months and 1 year post procedure	30 days, 6 months, 1 year 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.
Major ipsilateral stroke at 30 days, 6 months and 1 year post procedure	30 days, 6 months, 1 year 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.
All-cause mortality at 30 days, 6 months and 1 year post procedure	30 days, 180 days and 1 year post procedure	Deaths due to any cause are calculated.
Technical success	Intra-procedure	Technical success defined as stable stent placement with complete coverage across the aneurysm neck and parent artery patency.
In-Stent Stenosis at 6 months post procedure	6 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.
Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 6 months post procedure	6 months post procedure	Proportion of subjects with complete occlusion of the target aneurysm, ≤50% stenosis of the parent artery at the target intracranial aneurysms (IA) at 6 months as assessed by angiography, and in whom an unplanned alternative treatment of the target IA had not been performed within 6 months.
In-stent thrombosis at 6 months post procedure	6 months post procedure	Stent thrombosis defined as a thrombotic occlusion of a stent.
Rate of Device defect	within 1 year of whole trial	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.
Complete aneurysm occlusion at 6 months post procedure	6 months post procedure	Complete occlusion defined as complete obliteration of the aneurysm sac, including the neck (Raymond I).
Incidence of adverse events/serious adverse events during 30 days, 6 months and 1 year post procedure	30 days, 6 months and 1 year post procedure	Percentage (%) of participants who experienced adverse events/serious adverse events.
Success aneurysm occlusion immediately after the procedure	Immediately after the procedure	The percentage of aneurysms in which class 1 or 2 is achieved on the Raymond Scale immediately post-procedure angiographic assessments, will be evaluated.

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, China