Solitaire Aneurysm Remodeling Registry

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04905303

Enrollment

Registered

2021-05-27

Start date

2009-02-28

Completion date

2011-06-30

Last updated

2021-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Saccular Aneurysm, Either Rupture or Unruptured, Wide Neck Aneurysm

Keywords

Intracranial aneurysms, Wide neck aneurysms

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Countries

France

Outcome results