Stent-assisted Embolization for Wide-Necked Intracranial Aneurysm: a Multicenter Prospective Observational Registry Trial of Neuroform3TMstent in China

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-TNC-08000275

Enrollment

Unknown

Registered

2008-12-21

Start date

2009-01-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Wide-Necked Intracranial Aneurysm

Interventions

Wide-Necked Intracranial Aneurysm:Neuroform3TMstent-assisted Embolization for Wide-Necked Intracranial Aneurysm

Eligibility

Sex/Gender

All

Age

17 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 18 years old-75 years old; 2. Ruptured and unruptured wide-necked intracranial sac aneurysm; 3. Maximum diameter of the aneurysm is more than 3mm; 4. Neuroform3TMstent is thought to be a proper alternative in the thrombosis of aneurysm by doctor; 5. Patients are consent to the procedure; 6. Patients are consent to follow up.

Exclusion criteria

Exclusion criteria: 1. non-sac aneurysm (infection fusiform dissecting); 2. micro aneurysm (diameter is less than 3mm) or partially thrombosed giant aneurysm; 3. aneurysm failed to respond to prior surgical treatment; 4. patient with poor neurological grade for ruptured aneurysm (Hunt-Huss grade 4 or5); 5. mRS score is 4 or 5; 6. aneurysm that endovascular treatment is not a proper alternative; 7. stent is not advanced through the parent artery for severe vasospasm; 8. aneurysm associated with AVM or complicated with intracranial hematoma and cerebral tumaor; 9. other stents except Neuroform stent are used now or before; 10. pregnant or lactation female; 11. enrolled in other related clinical trial; 12. patients who are sensitive to platinum, PGLA , polymeric hydrogel and titanium allegation; 13. patients who can not live more than a year or be followed up; 14. complicated with carotid stenosis or Moyamoya disease; 15. patients who can not tolerate antiplatelet and anticoagulation; 16. patientswho can not tolerate contrast.

Design outcomes

Primary

Measure	Time frame
recurrence rate of aneurysm in 24 months, clinical death in 24 months, stenosis or thrombosis in stent;	—

Secondary

Measure	Time frame
aneurysms rupture or rerupture, aneurysms need retreatment in 24 months, serious hemotoma, complications;	—

Countries

China

Contacts

Public ContactJianmin Liu

liujjm8@163.com+86 0 13901780638

Outcome results

None listed

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