NCT04905303

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
10 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

May 24, 2021

Last Update Submit

May 24, 2021

Conditions

Intracranial Saccular Aneurysm, Either Rupture or UnrupturedWide Neck Aneurysm

Keywords

Intracranial aneurysmsWide neck aneurysms

Outcome Measures

Primary Outcomes (1)

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

    Six months post-implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with confirmed diagnosis of intracranial saccular aneurysm which can be treated with coil embolization and neurovascular stenting.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Neurologique

Lyon, France

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2021

First Posted

May 27, 2021

Study Start

February 1, 2009

Primary Completion

February 1, 2011

Study Completion

June 1, 2011

Last Updated

May 27, 2021

Record last verified: 2021-05

Locations

FR(1)