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A Prospective, Multicenter, Single Group Clinical Investigation:Evaluation of Safety and Effectiveness of KangFly® Micro Guidewire in the Neurovascular Interventional Procedure

A Prospective, Multicenter, Single Group Clinical Investigation:Evaluation of Safety and Effectiveness of KangFly® Micro Guidewire in the Neurovascular Interventional Procedure

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089098
Enrollment
Unknown
Registered
2024-09-02
Start date
2024-03-18
Completion date
Unknown
Last updated
2024-09-09

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

Conditions

None listed

Interventions

single-arm group:Neurovascular Interventional Procedure uses microguidewire-assisted instruments to reach the target site

Sponsors

Yichang Central People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.aged 18 - 85 years; 2.Neurovascular interventional procedure was planned; 3.Signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.The patient has undergone surgery or interventional therapy within 1 month; 2.The patient had a subarachnoid hemorrhage or intracranial hemorrhage within 2 months; 3.The patient has had active ulceration within 6 months; 4.The patient has a bleeding tendency disease or coagulation dysfunction, such as preoperative platelet count 180 / 100mmHg or BP <90 / 60mmHg); 6.The target aneurysm is a blood blister-like aneurysm, dissecting aneurysm, infectious aneurysm, or ruptured aneurysm; 7.Severe intracranial vascular tortuosity is not amenable to interventional therapy; 8.Suffering from cognitive impairment; 9.Pregnant or lactating females; 10.Ongoing participation in other clinical trials; 11.There are other contraindications to surgery (such as Severe allergy to anticoagulant/antiplatelet drugs, anesthetic drugs, contrast agents or Acute myocardial infarction, etc); 12.It is judged by the investigator to be unsuitable for inclusion in this trial.

Design outcomes

Primary

MeasureTime frame
Device success;

Secondary

MeasureTime frame
Acute procedure success;The incidence of adverse events;The incidence of serious adverse events;Device defects;

Countries

China

Contacts

Public ContactWang Lei

Yichang Central People's Hospital

onedy@sina.com+86 731 5684 1086

Outcome results

None listed

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