Intracranial Aneurysm
Conditions
Keywords
wide-necked cerebral aneurysms, Brain Aneurysm, Cerebral Aneurysm, Stent
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 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.
Interventions
DEVICESINOMED IAS Stent System
Stent-assisted coiling (SAC) of intracranial aneurysms paved the way for endovascular coiling of wide-neck aneurysms, improving rates of aneurysm obliteration and recurrence.
Stent-assisted coiling (SAC) of intracranial aneurysms paved the way for endovascular coiling of wide-neck aneurysms, improving rates of aneurysm obliteration and recurrence.
Sponsors
Sinomed Neurovita Technology Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary efficacy endpoint is complete aneurysm occlusion without retreatment or significant parent artery stenosis at 12 months post-procedure | 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. |
| The primary safety endpoint is the incidence of major ipsilateral stroke or neurogenic death within 12 months post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | Intra-procedure | Technical success defined as stable stent placement with complete coverage across the aneurysm neck and parent artery patency. |
| Complete aneurysm occlusion or success aneurysm occlusion immediately after the procedure | 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). |
| Success aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 12 months post procedure | 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. |
| Complete aneurysm occlusion or success aneurysm occlusion at 12 months post procedure | 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). |
| Retreatment Rate at 6 months and 12 months post procedure | 6 months, 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. |
| In-Stent Stenosis at 12 months post procedure | 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. |
| Modified Rankin Scale (mRS) at 30 days, 6 months and 12 months post procedure | 30 days, 6 months, 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. |
| Major ipsilateral stroke or neurogenic death at 30 days, 6 months post procedure | 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. |
| All-cause mortality at 30 days, 6 months and 12 month post procedure | 30 days, 180 days and 12 months post procedure | Deaths due to any cause are calculated. |
| Incidence of adverse events/serious adverse events during 30 days, 6 months and 12 month post procedure | 30 days, 6 months and 12 months post procedure | Percentage (%) of participants who experienced adverse events/serious adverse events. |
| In-stent thrombosis at 12 months post procedure | 12 months post procedure | Stent thrombosis defined as a thrombotic occlusion of a stent. |
| Rate of Device defect | within 12 months 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORxinJian Yang
Beijing Tiantan Hospital
Outcome results
None listed