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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
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This study aims to conduct a post-market, multicenter clinical trial utilizing an interventional robotic system for cerebral angiography. By comparing it with traditional angiography procedures, the study will systematically evaluate the efficacy and safety of robot-assisted angiography in real clinical settings. Researchers will compare the ordinary angiography to assess the clinical success rate, operation time, radiation absorption, complication rate, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Manual Endovascular Angiography | No Intervention | ||
| Vascular Interventional Robotic System Assisted Angiography | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular Interventional Robotic System | Device | The cerebral angiography will be performed by using the vascular interventional robotic system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Angiography Success Rate | Assessment of the success rate of the surgeon in completing cerebral angiography examination through the operation of vascular interventional robotic system or manual way. | At the end of surgery |
| Complication Rate | Potential complications include: ① Directly related to the interventional procedure: Vascular injury (vessel rupture, perforation, spasm, gas embolism, and thrombosis); ② Neurological complications: New-onset neurological deficits (transient/permanent), new-onset cerebral ischemia, or new-onset intracerebral hemorrhage, confirmed by postoperative imaging; ③ Systemic complications: Cardiac events, gastrointestinal bleeding, renal dysfunction, etc. | At the day after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Operation Time | Record and compare the duration of each surgical procedure. | At the end of surgery |
| Super-selective Success Rate | Assessing the success rate of the surgeon in performing super-selective catheterization of each cerebral vessels through the operation of vascular interventional robotic system or manual way. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100070 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37612055 | Result | Liu H, Li C, Ren S, Li T, Zhong H, Jia J, Yang H, Qi Y, Feng J, Li Y, Wang Y. Efficacy and safety of a neurointerventional operation robotic assistance system in cerebral angiography. Stroke Vasc Neurol. 2024 Jun 21;9(3):243-251. doi: 10.1136/svn-2022-002260. | |
| 40633938 | Result | Zhang Y, Xu H, Sun J, Chen WH, Zhang Y, Chen M, Yi T, Wu YM, Cheng G, Guo J, Yang P, Guo S, Liu J. Safety and efficacy of cerebral robot assisted angiography: randomized comparison of robotic versus manual procedures. J Neurointerv Surg. 2026 Apr 16;18(5):1330-1336. doi: 10.1136/jnis-2025-023412. |
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The vascular interventional robotic system includes proprietary technical features that are integral to the IPD. Publicly sharing IPD would inadvertently disclose proprietary information, which could compromise the manufacturer's intellectual property rights and hinder future development of the technology for broader clinical use.
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| At the end of surgery |
| Super-selective Catheterization Time for Vessels | Calculate and compare the average time taken for surgeon to perform super-selective catheterization for each target vessel during each surgical procedure. | At the end of surgery |
| Digital Subtraction Angiography (DSA) Fluoroscopy Time | Calculate and compare the average time of fluoroscopy during cerebral angiography for each surgical procedure. | At the end of surgery |
| Primary Operator Radiation Absorbed Dose | Record and compare the absorbed dose of radiation received by the primary operator during each surgical procedure. | At the end of surgery |
| Participant Radiation Absorbed Dose | Record and compare the absorbed dose of radiation received by the participant during each surgical procedure. | At the end of surgery |
| Vascular Interventional Robotic System Performance Evaluation | The surgical physician rate a score (0-10) after the surgery to subjectively evaluate the performance of the vascular interventional robotic system during the angiographic examination procedure. | At the end of surgery |
| Frequence of robotic operations transition to manual operations | Document the frequence where robotic operations transition to manual operations due to certain force majeure events. | At the end of surgery |
| Operation Preparation Time | Calculate and compare the time from when participants enter the operating room until the primary operator formal start the surgery. | At the end of Surgery |
| Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences |
| Beijing |
| Beijing Municipality |
| 100730 |
| China |
| 37468266 | Result | Beaman C, Gautam A, Peterson C, Kaneko N, Ponce L, Saber H, Khatibi K, Morales J, Kimball D, Lipovac JR, Narsinh KH, Baker A, Caton MT, Smith ER, Nour M, Szeder V, Jahan R, Colby GP, Cord BJ, Cooke DL, Tateshima S, Duckwiler G, Waldau B; Robotics Working Group; Robotic Working Group. Robotic Diagnostic Cerebral Angiography: A Multicenter Experience of 113 Patients. J Neurointerv Surg. 2024 Jun 17;16(7):726-730. doi: 10.1136/jnis-2023-020448. |