EffectiveNess and SAfety of Small ANeurysm COiling Trial

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

252 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ultra Coils From Start to Finish for the Endovascular Repair of Small Intracranial Aneurysms

NCT02657772

Intracranial Aneurysms

COMPLETED

Hydrogel Endovascular Aneurysm Treatment Trial

NCT01407952

Cerebral Aneurysm

COMPLETED NA

Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System

NCT01491945

Abdominal Aortic Aneurysm

COMPLETED NA

Treatment of Cranial Internal Carotid Artery Aneurysm With Willis Covered Stent and Coil Embolization

NCT01029938

Intracranial Aneurysms

UNKNOWN PHASE4

Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities

NCT04106583

Aneurysm, Brain

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aneurysm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No