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Clinical Trial on the Safety and Efficacy of Intravascular Optical Coherence Tomography System and Disposable Intracranial Artery Imaging Catheter for Intracranial Arterial Intraluminal Imaging

Clinical Trial on the Safety and Efficacy of Intravascular Optical Coherence Tomography System and Disposable Intracranial Artery Imaging Catheter for Intracranial Arterial Intraluminal Imaging

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109963
Enrollment
Unknown
Registered
2025-09-28
Start date
2025-10-15
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Arterial Stenosis

Interventions

OCT group:Intracranial Arterial Intraluminal OCT Examination

Sponsors

Changhai Hospital, the First Affiliated Hospital of Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years old and <= 85 years old; 2. Planned to undergo intracranial arterial endovascular interventional therapy or follow-up; 3.The subject or their legal representative voluntarily participates, signs the informed consent form, and is willing to receive relevant examinations and clinical follow-up.

Exclusion criteria

Exclusion criteria: 1.The tip of the microcatheter used to deliver the OCT catheter cannot reach the distal end of the target lesion; 2.Serum creatinine > 2.0 mg/dl; 3.Contrast medium allergy; 4.Bacteremia or septicemia; 5.Participation in other clinical trials within the past 1 month; 6.Other conditions deemed unsuitable for enrollment by the investigator.

Design outcomes

Primary

MeasureTime frame
Compliance Rate of Clear Image Length (CIL);

Secondary

MeasureTime frame
Image Quality Grading;Stability of the System Host;Maneuverability of the Catheter;Incidence rate of device-related adverse events;Device Defect;

Countries

China

Contacts

Public ContactJianmin Liu

Changhai Hospital, the First Affiliated Hospital of Naval Medical University

liu118@vip.163.com+86 21 3116 2332

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026