Status:
WITHDRAWN
Solitaire Aneurysm Remodeling Registry
Lead Sponsor:
Medtronic Neurovascular Clinical Affairs
Conditions:
Intracranial Saccular Aneurysm, Either Rupture or Unruptured
Wide Neck Aneurysm
Eligibility:
All Genders
18+ years
Brief Summary
The objective of the registry is to evaluate the effectiveness and performance of the Solitaire Neurovascular Remodeling Device when used with embolic coils in the treatment of intracranial aneurysms.
Eligibility Criteria
Inclusion
- Confirmed diagnosis of intracranial saccular aneurysms, either ruptured or unruptured
- Aneurysm requires current treatment with coils and a stent or aneurysm hs been previously treated with coils, but no prior placement of a stent.
- Aneurysm has a wide neck defined as having a neck equal to or greater than 4mm or a dome-to-neck ratio of \<2.
- Patient is 18 years or older.
- Patient has a Hunt \& Hess score of III or less.
Exclusion
- Patient has a fusiform or dissecting aneurysm type.
- Patient is contraindicated for either heparin or anti-platelet therapy.
- Patient has severe allergy to IV contrast medium.
- Patient has a known hypersensitivity to nickel-titanium.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04905303
Start Date
February 1 2009
End Date
June 1 2011
Last Update
May 27 2021
Active Locations (1)
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1
Hopital Neurologique
Lyon, France