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A prospective, multi-center, randomized controlled clinical trial for evaluating the safety and efficacy of blocked balloon catheters in blocking vascular blood flow on the upper branch artery of the arch and its branches

A prospective, multi-center, randomized controlled clinical trial for evaluating the safety and efficacy of blocked balloon catheters in blocking vascular blood flow on the upper branch artery of the arch and its branches

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020908
Enrollment
Unknown
Registered
2019-01-22
Start date
2019-01-26
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

Cerebral Ischemic Stroke

Interventions

Group 1:Blocking balloon catheter (Shanghai Xin Wei Medical Technology Co., Ltd.)
Group 2:Balloon Guide Catheters (trade name: Merci), concentric Medical, Inc.

Sponsors

Xuanwu Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged at least 18 years; 2. In interventional diagnosis and treatment surgery, suitable for temporary blocking of the arch artery and its branch vascular blood flow patients; 3. The patient or his or her guardian is able to understand the purpose of the experiment, voluntarily participate in the experiment and sign a written informed consent statement.

Exclusion criteria

Exclusion criteria: 1. Severe heart failure (NYHA heart function IV level); 2. Lung, liver and kidney failure; 3. History of allergies to contrast agents; 4. Those who cannot accept catheter interventional surgery; 5. There are severe coagulation dysfunction; 6. Women in pregnancy or lactation; 7. Those who are not being completed in clinical trials of other drugs or devices; 8. The researchers judged other situations that were not suitable for selection.

Design outcomes

Primary

MeasureTime frame
Instant Operation success Rate;

Secondary

MeasureTime frame
Surgical success Rate;

Countries

China

Contacts

Public ContactXunming Ji

Xuanwu Hospital of Capital Medical University

jixunming@vip.163.com+86 13911077166

Outcome results

None listed

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