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Clinical Trials/NCT04905303
NCT04905303
Withdrawn
Not Applicable

Prospective Multi-center, Single-arm Registry to Evaluate the Efficacy of the Solitaire AB Neurovascular Remodeling Device in the Treatment of Wide-neck Intracranial Aneurysms

Medtronic Neurovascular Clinical Affairs1 site in 1 countryFebruary 2009
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ConditionsIntracranial Saccular Aneurysm, Either Rupture or UnrupturedWide Neck Aneurysm

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intracranial Saccular Aneurysm, Either Rupture or Unruptured
Sponsor
Medtronic Neurovascular Clinical Affairs
Locations
1
Primary Endpoint
Stable Stent placement with complete coverage across the aneurysm neck with parent artery patency
Status
Withdrawn
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
June 2011
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Medtronic Neurovascular Clinical Affairs
Responsible Party
Sponsor

Eligibility Criteria

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 \<
  • •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.

Outcomes

Primary Outcomes

Stable Stent placement with complete coverage across the aneurysm neck with parent artery patency

Time Frame: Six months post-implant

Study Sites (1)

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