Solitaire Aneurysm Remodeling Registry

Withdrawn

• Conditions: Wide Neck Aneurysm; Intracranial Saccular Aneurysm, Either Rupture or Unruptured

• Registration Number: NCT04905303
• Lead Sponsor: Medtronic Neurovascular Clinical Affairs

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2011-02
• Study Completion: 2011-06
• Status Verified: 2021-05
• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-24
• Last Update Submitted: 2021-05-24
• Study First Posted: 2021-05-27
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stable Stent placement with complete coverage across the aneurysm neck with parent artery patency	Six months post-implant

Trial Locations

Locations (1)

Hopital Neurologique; 🇫🇷 Lyon, France