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A prospective, multicenter, randomized controlled, non-inferiority design clinical trial to evaluate the safety and efficacy of minimally invasive vascular interventional surgical assisted operating system and minimally invasive vascular interventional surgical assisted operating system for cerebroangiography with an instrument operating box

A prospective, multicenter, randomized controlled, non-inferiority design clinical trial to evaluate the safety and efficacy of minimally invasive vascular interventional surgical assisted operating system and minimally invasive vascular interventional surgical assisted operating system for cerebroangiography with an instrument operating box

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071998
Enrollment
Unknown
Registered
2023-05-31
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Cerebrovascular disease

Interventions

Test group:Experimental apparatus assisted cerebral angiography
Control group:Cerebral angiography was performed manually

Sponsors

The First Affiliated Hospital of Naval Medical University(Shanghai Changhai)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Age = 18; age =85 2) Those who plan to receive cerebral angiography 3) Voluntarily participated in the experiment and signed the informed consent

Exclusion criteria

Exclusion criteria: 1) Preoperative mRS Score > 2 2) Subjects who plan to receive surgical treatment at the same time during cerebrovascular angiography 3) Allergic to or intolerant to iodized contrast media 4) Allergy to interventional devices 5) severe heart, liver and kidney insufficiency 6) Active systemic infection exists 7) Severe vascular stenosis, occlusion or skin infection at the puncture site 8) Subjects with severe coagulopathy, bleeding tendency, or contraindication of anticoagulant drugs (such as heparin) 9) Subjects who have been enrolled in clinical studies of other devices or drugs for 3 months prior to screening 10) Female subjects of childbearing age during pregnancy and lactation 11) Other subjects deemed unsuitable for this study by the investigator

Design outcomes

Primary

MeasureTime frame
Clinical success rate;

Secondary

MeasureTime frame
Success rate of superselected technology;Target vessel superselection operation time;Perspective time;The main surgeon absorbed radiation dose;Radiation absorbed dose of subject;Instrument performance evaluation;

Countries

china

Contacts

Public ContactLiuJianmin

The First Affiliated Hospital of Naval Medical University(Shanghai Changhai)

liu118@vip.163.com+86 21 3116 1784

Outcome results

None listed

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