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A prospective, multicenter, single arm clinical trial of the safety and efficacy of SeparGate balloon-guiding catheter

A prospective, multicenter, single arm clinical trial of the safety and efficacy of SeparGate balloon-guiding catheter

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800014459
Enrollment
Unknown
Registered
2018-01-16
Start date
2018-01-18
Completion date
Unknown
Last updated
2018-01-29

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

Conditions

Cerebrovascular Disease

Interventions

SeparGate balloon-guiding catheter:Using The SeparGate balloon-guiding catheter in interventional therapy.

Sponsors

Henan Provincial People' Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) between 18-80 years old; 2) the patient who need temporarily block the blood flow of the supra-aortic arch and branch vessels in the interventional therapy; 3) the patient or guardian agrees to participate in the study and have signed the informed consent.

Exclusion criteria

Exclusion criteria: 1) heart, lung, liver and kidney failure or other serious diseases; 2) generalized infection; 3) severe coagulation disorders; 4) history of severe allergy to contrast medium; 5) refuse the interventional therapy; 6) pregnancy or lactating female; 7) life expectancy is less than 30 days; 8) actively participating in another drug or device trial.

Design outcomes

Secondary

MeasureTime frame
Product Property;

Primary

MeasureTime frame
The Immediate operation success rate;

Countries

China

Contacts

Public ContactTianxiao Li

Department of Interventional, Henan Provincial People' Hospital, He'nan Provincial People's Hospital

dr.litianxiao@vip.163.com+86 18603869791

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 27, 2026