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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SINOMED IAS Stent System | Experimental | The SINOMED IAS Stent System is intended for use with occlusive devices in the treatment of intracranial aneurysms. |
|
| Neuroform Atlas Stent System | Active Comparator | The Neuroform Atlas Stent System is intended for use with occlusive devices in the treatment of intracranial aneurysms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Technical success defined as stable stent placement with complete coverage across the aneurysm neck and parent artery patency. | Intra-procedure |
| Success aneurysm occlusion immediately after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| xinJian Yang | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Beijing | China |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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. |
|
The percentage of aneurysms in which class 1 or 2 is achieved on the Raymond Scale immediately post-procedure angiographic assessments, will be evaluated.
| Immediately after the procedure |
| Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 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. | 6 months post procedure |
| Complete aneurysm occlusion at 6 months post procedure | Complete occlusion defined as complete obliteration of the aneurysm sac, including the neck (Raymond I). | 6 months post procedure |
| Retreatment Rate at 6 months and 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. | 6 months, 1 year post procedure |
| In-Stent Stenosis at 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. | 6 months post procedure |
| Modified Rankin Scale (mRS) at 30 days, 6 months and 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. | 30 days, 6 months, 1 year post procedure |
| Major ipsilateral stroke at 30 days, 6 months and 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. | 30 days, 6 months, 1 year post procedure |
| All-cause mortality at 30 days, 6 months and 1 year post procedure | Deaths due to any cause are calculated. | 30 days, 180 days and 1 year post procedure |
| Incidence of adverse events/serious adverse events during 30 days, 6 months and 1 year post procedure | Percentage (%) of participants who experienced adverse events/serious adverse events. | 30 days, 6 months and 1 year post procedure |
| In-stent thrombosis at 6 months post procedure | Stent thrombosis defined as a thrombotic occlusion of a stent. | 6 months post procedure |
| 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. | within 1 year of whole trial |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |