Solitaire Aneurysm Remodeling Registry

NCT ID: NCT04905303

Last Updated: 2021-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Intracranial Saccular Aneurysm, Either Rupture or Unruptured Wide Neck Aneurysm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Neurovascular Clinical Affairs

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopital Neurologique

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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SOLARE

Identifier Type: -

Identifier Source: org_study_id

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