Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Phenox GmbH | INDUSTRY |
| Beijing Wallaby Medical Technologies Co.,Inc. | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess safety and effectiveness of the pEGASUS stent system.
Title: A prospective, multicenter, single-arm clinical trial to evaluate the safety and efficacy of pEGASUS stent system for assisted endovascular treatment of intracranial aneurysms Device: pEGASUS stent system Design: Prospective, Multicenter, Single Arm Clinical Study. Purpose: To assess safety and effectiveness of the pEGASUS stent system. Study duration: 31 months. Sample Size: 130 patients. Number of sites: ≤10. Follow-up time: 12 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Patients can be included in the study if they meet all of the inclusion and none of the exclusion criteria and have provided written informed consent, intent to use pEGASUS stent system assisted to treat intracranial aneurysm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pEGASUS Stent System | Device | Endovascular intervention with p64/p48 MW HPC pEGASUS Stent System was performed in patients diagnosed with intracranial aneurysms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aneurysm Occlusion of the Treated Target Lesion on 6 Month Angiography | Complete aneurysm occlusion (100% occlusion - Raymond Class 1) of the treated target lesion on 6 month angiography, in the absence of retreatment, or parent artery stenosis (> 50%) at the target location. | 6 months |
| Rate of major ipsilateral stroke or neurological death | Any major ipsilateral stroke or neurological death | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | Technical success is defined as the successful placement of pEGASUS stent system. | Within 24 hours after surgery |
| Rate of successful occlusion | Aneurysm successful occlusion is defined as Raymond Grade I/II. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenwen Jia | Contact | +86 18818201005 | wendy.jia@wallabyphenox.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianmin Liu | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | 222018 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Within 24 hours after surgery, 6 months, 12 months |
| Rate of complete occlusion | Aneurysm complete occlusion is defined as Raymond Grade I. | Within 24 hours after surgery, 6 months, 12 months |
| Rate of good clinical prognosis | Good clinical prognosis means mRS 0~2 | 3 months, 6 months, 12 months |
| Death, stroke, and thrombotic events | Record the number of death, stroke and thrombotic events throughout the clinical trial period. | to 12 months |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |