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NCT Number: NCT07182188

A Clinical Trial of Vascular Interventional Robotic System for Cerebral Angiography

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Vascular Interventional Robotic System

Device

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

Primary outcomes

  1. Angiography Success Rate

    Time frame: At the end of surgery

    Assessment of the success rate of the surgeon in completing cerebral angiography examination through the operation of vascular interventional robotic system or manual way.

  2. Complication Rate

    Time frame: At the day after surgery

    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.

Secondary outcomes

  1. Operation Time

    Time frame: At the end of surgery

    Record and compare the duration of each surgical procedure.

  2. Super-selective Success Rate

    Time frame: At the end of surgery

    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.

  3. Super-selective Catheterization Time for Vessels

    Time frame: At the end of surgery

    Calculate and compare the average time taken for surgeon to perform super-selective catheterization for each target vessel during each surgical procedure.

  4. Digital Subtraction Angiography (DSA) Fluoroscopy Time

    Time frame: At the end of surgery

    Calculate and compare the average time of fluoroscopy during cerebral angiography for each surgical procedure.

  5. Primary Operator Radiation Absorbed Dose

    Time frame: At the end of surgery

    Record and compare the absorbed dose of radiation received by the primary operator during each surgical procedure.

  6. Participant Radiation Absorbed Dose

    Time frame: At the end of surgery

    Record and compare the absorbed dose of radiation received by the participant during each surgical procedure.

  7. Vascular Interventional Robotic System Performance Evaluation

    Time frame: At the end of surgery

    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.

  8. Frequence of robotic operations transition to manual operations

    Time frame: At the end of surgery

    Document the frequence where robotic operations transition to manual operations due to certain force majeure events.

  9. Operation Preparation Time

    Time frame: At the end of Surgery

    Calculate and compare the time from when participants enter the operating room until the primary operator formal start the surgery.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Beijing Tiantan Hospital

Registry information

Official study title

Post-Market Application Study and Efficacy/Safety Evaluation of a Vascular Interventional Robotic System for Cerebral Angiography: A Multicenter Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.