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Preliminary trial of domestic flow diverter device Repath in the treatment of intracranial aneurysm

Preliminary trial of flow diverter device in the treatment of intracranial aneurysm

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029398
Enrollment
Unknown
Registered
2020-01-29
Start date
2019-01-01
Completion date
Unknown
Last updated
2020-02-03

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

Conditions

intracranial aneurysm

Interventions

1:Flow diverter placement

Sponsors

First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. age 18-90 years old; 2. intracranial aneurysms locate in anterior or posterior circulation; 3. diameter of parent artery varies from 2.5mm to 6.0mm; 4. The subject or legal representatives understand the purpose of this study with good compliance and signed the consent form; 5. Subjects with intracranial aneurysms that can be stented only or coiled-assisted stented.

Exclusion criteria

Exclusion criteria: 1. Subarachnoid hemorrhage occurred 60 days before admission; 2. Had major surgery 30 days before enrollment or planed major surgery 90 days after enrollment; 3. With irreversible hemorrhagic disease, platelet count is less than 100x10^3 / mm3 cannot take or tolerate antiplatelet drugs; 4. Ruptured intracranial aneurysm; 5. Intracranial aneurysm associated with AVM; 6. Lesions research determined not suitable for the stent navigation; 7. Intracranial aneurysm primarily stented by other stents; 8. Serum creatinine >=2.5 mg/dl; 9. mRS>=4; 10. Life expectancy is less than 12 months; 11. Contraindications to dual antiplatelet therapy (aspirin and clopidogrel); 12. Did not take dual antiplatelet therapy (aspirin and clopidogrel) before procedure.

Design outcomes

Primary

MeasureTime frame
immediate procedure success rate;Occlusion of aneurysm;

Countries

China

Contacts

Public ContactSheng Guan

First Affiliated Hospital of Zhengzhou University

gsradio@126.com+86 13673665399

Outcome results

None listed

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