Registry for Study of Coils in Intracranial Aneurysms

NCT01000675 | Completed

• 1 other identifier: 09-002933
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The current proposal describes a post-market, clinical registry of HydroSoft, aimed at gaining robust clinical data in a large set of patients to better define the advantages, and potentially, the disadvantages of the HydroSoft, and to inform future randomized trials.

Conditions

Cerebral Aneurysms

Keywords

aneurysm; coils

Outcome Measures

Primary Outcomes (1)

• We will compare recanalization or recurrence rates observed in this prospective registry of HydroSoft coils used as finishing coils to historical series of aneurysms treated with bare platinum coils.

  6 - 18 months post coiling

Secondary Outcomes (1)

• HydroSoft embolic coil can be placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure.

  6 - 18 months post coiling

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All people with cerebral aneurysms between the ages of 21 and 90 that are treated with coils.

You may qualify if:

• Patient presenting with a ruptured or un-ruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular team (neurosurgeon/neurointerventionist)
• Patient age: patients aged between 21 and 90 years will be eligible.
• Patient HUNT AND HESS Grade 0-3.
• Patient has given fully informed consent to endovascular coiling procedure or if patient cannot consent for themselves, appropriate written consent has been sought from their next of kin, or from appropriate power of attorney.
• Aneurysm 3-15mm in maximum diameter.
• Patient is willing and able to return for follow up angiography or MRA between 6-18 months.
• The patient has not been previously entered into this registry
• The aneurysm has not previously been treated (by coiling or clipping).

You may not qualify if:

• Inability to obtain informed consent.
• Medical or surgical comorbidity such that the patient's life expectancy is less than 1 year.

Sponsors & Collaborators

• Mayo Clinic: lead
• Abbott: collaborator
• Albany Medical College: collaborator
• Asan Medical Center: collaborator
• Baylor University: collaborator
• Bronson Methodist Hospital: collaborator
• Capital Health, Canada: collaborator
• The Cleveland Clinic: collaborator
• Dalhousie University: collaborator
• Fudan University: collaborator
• Fort Sanders Regional Medical Center: collaborator
• JFK Medical Center, Florida: collaborator
• Kobe City Medical Center: collaborator
• Methodist Research Institute, Indianapolis: collaborator
• Medical University of South Carolina: collaborator
• Providence Health & Services: collaborator
• Scott and White Hospital & Clinic: collaborator
• Stony Brook University: collaborator
• Thomas Jefferson University: collaborator
• Royal University Hospital Foundation: collaborator
• University of California, Los Angeles: collaborator
• University of Florida: collaborator
• University of Maryland: collaborator
• University of Oklahoma: collaborator
• University of Southern California: collaborator
• Washington University School of Medicine: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Brinjikji W, Amar AP, Delgado Almandoz JE, Diaz O, Jabbour P, Hanel R, Hui F, Kelly M, Layton KD, Miller JW, Levy E, Moran C, Suh DC, Woo H, Sellar R, Ho B, Evans A, Kallmes DF. GEL THE NEC: a prospective registry evaluating the safety, ease of use, and efficacy of the HydroSoft coil as a finishing device. J Neurointerv Surg. 2018 Jan;10(1):83-87. doi: 10.1136/neurintsurg-2016-012915. Epub 2017 Jan 30.

  PMID: 28138062 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• David F Kallmes, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David F Kallmes, MD, Mayo Clinic

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 23, 2009
• Study Start: August 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2016
• Last Updated: June 6, 2019

Record last verified: 2019-06

Locations

US (1)