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

Sinomed Neurovita Technology Inc.203 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

203

Conditions

Intracranial Aneurysm

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (14)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

West China Hospital of Sichuan University

Chengdu, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 12 months post-procedure

Secondary Outcomes

Technical success

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

Time frame: Intra-procedure

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).

Time frame: Immediately after the procedure

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.

Data from ClinicalTrials.gov

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