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| Name | Class |
|---|---|
| Phenox GmbH | INDUSTRY |
| Beijing Wallaby Medical Technologies Co.,Inc. | UNKNOWN |
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The purpose of this study is to assess safety and effectiveness of the p64/p48 MW HPC Flow Modulation Device.
Title: A prospective, multicenter, single arm clinical trial to evaluate the safety and effectiveness of Flow Modulation Device for intracranial aneurysms.
Device: p64/p48 MW HPC Flow Modulation Device. Study design: Prospective, multicenter, single arm Clinical Study.
Purpose: To assess safety and effectiveness of p64/p48 MW HPC Flow Modulation Device .
Study duration: 32 months. Sample Size: 120 patients. Number of sites: ≤10. Follow-up time: 12 months.
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| 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 Flow modulation device to treat intracranial aneurysm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| p64/p48 MW HPC Flow Modulation Device | Device | Endovascular intervention with p64/p48 MW HPC Flow Modulation Device was performed in patients diagnosed with intracranial aneurysms |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complete occlusion | Raymond grade was evaluated by the independent imaging evaluation Committee 12 months after surgery according to the subjects' imaging results, and the rate of complete aneurysm occlusion was calculated. Aneurysm complete occlusion is defined as Raymond Grade I. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | Technical success is defined as the successful placement of a Flow Modulation Device. Successful implantation means that the Flow Modulation Device is placed at the target site and effectively covers the neck of the aneurysm, and the rest of the device is successfully released and withdrawn to the outside of the body. | Within 24 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenwen Jia | Contact | +86 18818201005 | Wendy.Jia@wallabyphenox.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongqi Zhang | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | 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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| Rate of successful occlusion | Raymond grade was evaluated by the independent imaging evaluation Committee 6 months and 12 months after surgery according to the subjects' imaging results, and the rate of successful aneurysm occlusion was calculated. Aneurysm successful occlusion is defined as Raymond Grade I/II. | 6 months, 12 months |
| Rate of complete occlusion | Raymond grade was evaluated by the independent imaging evaluation Committee 6 months after surgery according to the subjects' imaging results, and the rate of complete aneurysm occlusion was calculated. Aneurysm complete occlusion is defined as Raymond Grade I. | 6 months |
| Rate of good clinical prognosis | Good clinical prognosis means mRS 0~2 | 3 months, 6 months, 12 months |
| Rate of in-stent-stenosis | In-stent-stenosis defined as moderate or severe stenosis of the tumor artery, that is, stenosis > 50% | to 6 months, to 12 months |
| Device performance evaluation | After each use of the device, the researchers evaluated the operational performance of the device in terms of conveying, flexibility, compliance and wall adhesion. | Within 24 hours after surgery |
| 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 |