A Clinical Trial of Vascular Interventional Robotic System for Cerebral Angiography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2027-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Crerbral Angiography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Traditional Manual Endovascular Angiography

Group Type NO_INTERVENTION

No interventions assigned to this group

Vascular Interventional Robotic System Assisted Angiography

Group Type EXPERIMENTAL

Vascular Interventional Robotic System

Intervention Type DEVICE

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

Interventions

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Vascular Interventional Robotic System

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age between 18 and 75 years;
2. 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;
3. American Society of Anesthesiologists (ASA) physical status classification I-III (no severe cardiopulmonary dysfunction);
4. Patients who voluntarily participate in this study and sign an informed consent form.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No