Solitaire Aneurysm Remodeling Registry

Medtronic

Status: Withdrawn

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04905303

SOLARE

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.