A Clinical Trial of Vascular Interventional Robotic System for Cerebral Angiography

NCT07182188 | Active Not Recruiting

• 1 other identifier: MR-11-24-024538
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Crerbral Angiography

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (9)

• Operation Time

  At the end of surgery

• Super-selective Success Rate

  At the end of surgery

• Super-selective Catheterization Time for Vessels

  At the end of surgery

• Digital Subtraction Angiography (DSA) Fluoroscopy Time

  At the end of surgery

• Primary Operator Radiation Absorbed Dose

  At the end of surgery

Study Arms (2)

Traditional Manual Endovascular Angiography

NO INTERVENTION

Vascular Interventional Robotic System Assisted Angiography

EXPERIMENTAL

Device: Vascular Interventional Robotic System

Interventions

Vascular Interventional Robotic System DEVICE

The cerebral angiography will be performed by using the vascular interventional robotic system

Vascular Interventional Robotic System Assisted Angiography

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years;
• Suspected vascular lesions in the head and neck, or other conditions involving head and neck vessels requiring whole-brain angiography for definitive diagnosis or to aid treatment decisions. Including but not limited to: intracranial aneurysms, arteriovenous malformations, cavernous malformations, arteriovenous fistulas, Moyamoya disease, Moyamoya syndrome, subarachnoid hemorrhage, symptomatic intracranial artery stenosis/occlusion, stenosis/occlusion of the carotid/subclavian/vertebral arteries, acute/ chronic subdural hematoma, etc;
• American Society of Anesthesiologists (ASA) physical status classification I-III (no severe cardiopulmonary dysfunction);
• Patients who voluntarily participate in this study and sign an informed consent form.

You may not qualify if:

• Patients who are to undergo surgery at the same time as cerebral angiography;
• Renal dysfunction (serum creatinine \> 133 μmol/L or estimated glomerular filtration rate \< 60 mL/min/1.73 m²);
• Patients with known allergy to iodinated contrast media;
• Coagulation disorders (prothrombin time \>16s, activated partial thromboplastin time \>45s, or platelet count \<100×10⁹/L);
• Severe infection, skin ulceration, or vascular anatomical abnormalities at the puncture site (e.g., bilateral femoral artery occlusion);
• Pregnant or lactating women;
• Patients with severe cognitive impairment;
• Patients with psychiatric disorders;
• Patients unable to undergo head magnetic resonance imaging (MRI), e.g., those with metallic implants, claustrophobia, or other contraindications;
• Patients with other severe advanced or terminal illnesses;
• Patients currently participating in other clinical trials.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Beijing Tiantan Hospital: collaborator
• The First Hospital of Hebei Medical University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Tangshan Worker's Hospital: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• The First People's Hospital of Lianyungang: collaborator

Study Sites (2)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (3)

• 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.

  PMID: 37612055 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.

  PMID: 40633938 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.

  PMID: 37468266 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Neurosurgery

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 19, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)