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A prospective, multicenter, randomized controlled clinical trial with open-label treatment and blinded endpoint assessment.
The PARAT-MT is to evaluate whether small unruptured cerebral aneurusm patients treated with FD superior to those treated with conventional endovascular therapy. It is a prospective, multicenter, randomized controlled clinical trial with open-label treatment and blinded endpoint assessment trial.
Primary Outcome Endpoint A composite endpoint of major recurrence, any stroke or death at one year post-surgery.
Second Outcome Endpoint
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Flow diversion for endovascular treatment of intracranial aneurysms |
|
| Control group | Active Comparator | Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flow Diversion for Endovascular Treatment of Intracranial Aneurysms | Device | Flow Diversion for Endovascular Treatment of Intracranial Aneurysms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major recurrence, any stroke or death | A composite endpoint of major recurrence, any stroke or death | At 1 year post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All-cause mortality | At 12 months post-surgery |
| Any stroke | Any stroke | At 12 months post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pengfei Yang, MD, PhD | Contact | 86-21-31161784 | 15921196312@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianmin Liu, MD, PhD | Changhai Hospital | Principal Investigator |
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Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to Oriental Collaboration group on Emerging Advanced therapy for Neurovascular diseases Consortium.
Data sharing will be available from 12 months after the publication of the main results.
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| Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms | Device | Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms |
|
| Major recurrence | Major recurrence | At 12 months post-surgery |
| Transient ischemic attack (TIA) | Transient ischemic attack (TIA) | At 12 months post-surgery |
| Procedure-related complications | Procedure-related complications | Periprocedural (30 days) |
| Ipsilateral stroke or neurologic death | Ipsilateral stroke or neurologic death | At 1 month and 12 months post-surgery |
| Severe disability | Severe disability (mRS > 2) | At 1 month and 12 months post-surgery |
| Complete aneurysm occlusion | Complete aneurysm occlusion (Raymond I) | at 12 months post-surgery |
| The rate of in-stent stenosis ≥50% | The rate of in-stent stenosis ≥50% | At 12 months post-surgery |
| hemorrhagic stroke | Incidence of hemorrhagic stroke | at 12 months post-surgery |
| Technical success rate | Technical success rate | 24 hours after endovascular treatment |
| Target parent artery retreatment rate | Target parent artery retreatment rate | At 12 months post-surgery |
| Target aneurysm retreatment rate | Target aneurysm retreatment rate | At 12 months post-surgery |
| Surgical operation time | Surgical operation time | during surgery |
| Radiation dose | Radiation dose | during surgery |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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