intracranial aneurysm
Conditions
Interventions
Repath placement group:Repath placement with or without coiling
Tubridge placement group:Tubridge placement with or without coiling
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)18-75 years old, male or unpregnant female; 2)Unruptured intracranial aneurysms locate in anterior or posterior circulation, including saccular aneurysms and recurrent aneurysms; 3)The aneurysm has >= 4 mm neck and >= 10 mm max diameter; 4) Parent artery diameter varies from 2.5mm to 6.0mm; 5)Suitable to be treated with Repath or Tubridge stent with or without coiling. 6) The subject or legal representatives understand the purpose of this study with good compliance and signed the consent form; 7)Subjects with intracranial aneurysms that can be stented only or coiled-assisted stented.
Exclusion criteria
Exclusion criteria: 1)Lesions with no suitable vascular approach; 2) Intracranial aneurysm associated with AVM; 3) Ruptured intracranial aneurysm; 4) Lesions not suitable for the stent navigation; 5) With planed surgery within 30 days; 6) mRS >=4; 7) Life expectancy is less than 12 months; 8) Subjects have participated in clinical trials of other drugs or medical devices and have not reached end point; 9) Subjects with poor compliance; 10) With clear history of allergy to NiTi alloy and or cobalt base alloy and platinum tungsten alloy; 11) Contraindications to dual antiplatelet therapy and anticoagulation therapy; 12) With possible or clear history of severe allergy to contrast media.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| occlusion of aneurysm; | — |
Secondary
| Measure | Time frame |
|---|---|
| immediate procedure success rate; | — |
Countries
China
Contacts
Public ContactSheng Guan
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed