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| Name | Class |
|---|---|
| Tianjin Happy Life Technology Co., Ltd. | INDUSTRY |
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The study objective is to evaluate the safety and effectiveness of Intracranial Distal Access Catheter in neurointerventional therapy.
Patients with mechanical thrombectomy for acute ischemic stroke, treatment of intracranial aneurysms and other ischemic and hemorrhagic diseases, requiring the use of Intracranial Distal Access Catheter to complete the procedure were eligible. At last, 124 retrospective and prospective subjects in 6 centers were screened in this trial, and 114 subjects were successfully enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects who using the Intracranial Distal Access Catheter to complete the procedure | Patients with mechanical thrombectomy for acute ischemic stroke, treatment of intracranial aneurysms and other ischemic and hemorrhagic diseases, requiring the use of Intracranial Distal Access Catheter to complete the procedure (such as poor vascular access conditions, lesions located in secondary or higher branches of cerebral vessels, inability of conventional guiding catheters in place and providing effective support. Treatment with Flow-divert devices, covered stents, etc.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracranial Distal Access Catheter | Device | Patients with mechanical thrombectomy for acute ischemic stroke, treatment of intracranial aneurysms and other ischemic and hemorrhagic diseases, requiring the use of Intracranial Distal Access Catheter(X-Track) to complete the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | It is defined as the proportion of subjects where Intracranial Distal Access Catheter can reach the expected position to successfully deliver the device and meet the treatment needs. Special note: If the patient uses more than one Intracranial Distal Access Catheters during the procedure, as long as any Intracranial Distal Access Catheter is delivered successfully, the patient is considered to achieve successful delivery with Intracranial Distal Access Catheter. Technical success rate (%) = number of patients successfully delivered/number of patients analyzed * 100% | immediately after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Catheter delivery success rate | It is defined as the proportion of Intracranial Distal Access Catheter where Intracranial Distal Access Catheter can reach the expected position to successfully deliver the device and meet the treatment needs. Special note: If the patient uses more than one Intracranial Distal Access Catheters during the procedure, the statistics are based on whether the delivery of each Intracranial Distal Access Catheter is successful or not. Catheter delivery success rate (%) = number of successful catheter delivery/total number of catheters used * 100% |
| Measure | Description | Time Frame |
|---|---|---|
| Device operation performance (device compatibility) | The evaluation of device compatibility is to evaluate whether it can be compatible with other devices(such as Coils, Flow-divert devices, Stenosis stents, Thrombectomy Stents ) The evaluation criteria for device compatibility is
| intra-procedure |
| Device operation performance (supporting capability) |
Inclusion Criteria:
Exclusion Criteria:
Ordinary guiding catheters can be used to establish access to complete the procedure without the use of Intracranial Distal Access Catheter.
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Patients with mechanical thrombectomy for acute ischemic stroke, treatment of intracranial aneurysms and other ischemic and hemorrhagic diseases, requiring the use of Intracranial Distal Access Catheter to complete the procedure (such as poor vascular access conditions, lesions located in secondary or higher branches of cerebral vessels, inability of conventional guiding catheters in place and providing effective support. Treatment with Flow-divert devices, covered stents, stent grafts, etc.)
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| Name | Affiliation | Role |
|---|---|---|
| JUN DONG, Associate chief physician | Rizhao People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhangzhou Municipal Hospital of Fujian Province | Zhangzhou | Fujian | China | |||
| Jiangmen Xinhui District People's Hospital |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| immediately after procedure |
| Incidence of device-related adverse events | from the procedure to patients discharged from the hospital, anticipated average 5 days |
| Incidence of device-related serious adverse events | from the procedure to patients discharged from the hospital, anticipated average 5 days |
The evaluation criteria for supporting capacity are as follows:
|
| intra-procedure |
| Device operation performance (pushing resistance) | The evaluation criteria for pushing resistance are as follows:
| intra-procedure |
| Jiangmen |
| Guangdong |
| China |
| Xinxiang Central Hospital | Xinxiang | Henan | China |
| The Sixth People's Hospital of Nantong | Nantong | Jiangsu | China |
| People's Hospital of Rizhao | Rizhao | Shandong | China |
| The Affiliated Hospital of Yunnan University | Kunming | Yunnan | China |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020765 | Intracranial Arterial Diseases |
| D000783 | Aneurysm |