EffectiveNess and SAfety of Small ANeurysm COiling Trial

Aneurysm Clinical Trial

— NANO  

Official title:

EffectiveNess and SAfety of Small ANeurysm COiling Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02167997
• Other study ID #: 17155
• Status: Recruiting
• Phase: N/A
• First received: June 17, 2014
• Last updated: August 17, 2016
• Start date: November 2013
• Est. completion date: December 2018

Study information

• Verified date: August 2016
• Source: University of Virginia
• Contact: Claire L McKinley, CCRP
• Phone: 434-924-9271
• Email: cw9ne[@]virginia.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To compare the safety and efficacy of treating small aneurysms with coils specially designed for small aneurysms to historically reported rates of safety and efficacy for the treatment of larger aneurysms.

Description:

This is a prospective cohort study whereby patients who undergo endovascular treatment with coils for intracranial aneurysms will be studied for initial procedural and 12-18 month post-treatment outcome. The procedural failure rate (defined above) of treating small aneurysms with specially designed coils will be compared to pre-specified historical occurrences. This evaluation will occur within the framework of "non-inferiority" (i.e. comparable success to coiling of large aneurysms).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patient presenting with a ruptured or un-ruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular team (neurosurgeon/neurointerventionalist)

• Patients between (and including) 18 and 90 years of age.

• Patient HUNT AND HESS Grade 0-3.

• Where required, patient has given fully informed consent to endovascular coiling procedure. If patient cannot consent for themselves, appropriate written consent has been sought from their surrogate, or from appropriate power of attorney.

• Aneurysm < 4mm in maximum diameter.

• Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography or MRA) at both 6-months and 12-18 months after endovascular treatment.

• The aneurysm has not previously been treated (by coiling or clipping).

• A three-dimensional angiogram has been performed.

• Placement of at least one "Nano" coil, at, or at least close to the neck of the aneurysm.

Exclusion Criteria:

• Patient has more than one aneurysm requiring treatment in the current treatment session. If a patient has multiple aneurysms, but only one will be treated at the time of enrollment, they are eligible for the trial. (Additional aneurysms may be treated at a later date, and may be treated with any coil type that the operator chooses).

• Patient has an H&H score of 4 or 5 after subarachnoid hemorrhage (SAH).

• Medical or surgical co-morbidity such that the patient's life expectancy is less than 1 year.

• Less than 80% by length of Stryker endovascular coils are implanted.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm

Locations

Country	Name	City	State
Canada	CHUM - Hôpital Notre-Dame Hospital	Montreal	Quebec
Canada	University of Saskatchewan	Saskatoon	Saskatchewan
United States	University of Virginia	Charlottesville	Virginia
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Radiology Imaging Associates	Englewood	Colorado
United States	University of Florida	Gainesville	Florida
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Lyerly Neurosurgery, Affiliate of Baptist Health	Jacksonville	Florida
United States	Norton Neuroscience Institute	Louisville	Kentucky
United States	Aurora Research Institute	Milwaukee	Wisconsin
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Riverside Research and Discovery- Riverside Health System	Newport News	Virginia
United States	The University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Maine Medical Center	Scarborough	Maine
United States	Swedish Neurosciences Research	Seattle	Washington
United States	Sentara Neuroscience Institute	Virginia Beach	Virginia
United States	University of Massachusettes	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	Stryker Neurovascular

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural failure	Defined as the composite of technical failure (inability to coil the aneurysm), and complication leading to permanent neurologic injury or death. The second primary outcome relates to the long term effectiveness of the procedure, and is defined as freedom from angiographic recurrence within a period of 12-18 months after the index procedure.	18 Months	No