Recruiting

SANCO TrialEffectiveNess and SAfety of Small ANeurysm COiling Trial

Sponsor:

University of Virginia

Code:

NCT02167997

Conditions

Aneurysm

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Aneurysm

Study ID

NCT02167997

Start date

Nov, 2013

Status verified date

Aug, 2016

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not 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.

Study Design

Enrollment

252 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

Procedural failure [ Time Frame: 18 Months ]

Central Contacts and Locations

Central contacts

Claire L McKinley, CCRP

434-924-9271 cw9ne@virginia.edu

Locations

Santa Barbara Cottage Hospital

Recruiting

Santa Barbara, California, United States, 93105

Contacts

Sharon Granoff

research@sbch.org

Principal Investigator:

Alois Zauner, MD

Radiology Imaging Associates

Recruiting

Englewood, Colorado, United States, 80112

Contacts

Michelle Lexin

Michelle.Lexin@riaco.com

Principal Investigator:

Richard Bellon, MD

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Jessica Smith

Jessica.Smith@neurosurgery.ufl.edu

Principal Investigator:

Adam Polifka, MD

Lyerly Neurosurgery, Affiliate of Baptist Health

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Nancy Ebreo

Nancy.Ebreo@bmcjax.com

Principal Investigator:

Eric Sauvageau, MD

Norton Neuroscience Institute

Recruiting

Louisville, Kentucky, United States, 40241

Contacts

Sherry Roberts

Sherry.Roberts@nortonhealthcare.org

Principal Investigator:

Shervin Dashti, MD

Maine Medical Center

Recruiting

Scarborough, Maine, United States, 04074

Contacts

Deborah Cushing

CUSHID@mmc.org

Principal Investigator:

Matthew Sanborn, MD

University of Massachusettes

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Mary Howk

mary.howk@umassmed.edu

Principal Investigator:

Ajit Puri, MD

Abbott Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Jennifer Fease

jennifer.fease@allina.com

Principal Investigator:

Josser Delgado, MD

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Jana Tancredi

JTancredi@HackensackUMC.org

Principal Investigator:

Daniel Walzman, MD

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Kathryn Jelinek

Kathryn.Jelinek@osumc.edu

Principal Investigator:

Patrick Youssef, MD

The University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Brittany Smith

Brittany-Smith@ouhsc.edu

Principal Investigator:

Steven Hoover, MD

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Alberto Montano

Alberto.Montano@jefferson.edu

Principal Investigator:

Stavropoula Tjoumakaris, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Claire McKinley

cw9ne@virginia.edu

Principal Investigator:

Avery J Evans, MD

Riverside Research and Discovery- Riverside Health System

Recruiting

Newport News, Virginia, United States, 23601

Contacts

Cheryl White

Cheryl.White@rivhs.com

Principal Investigator:

J. Frank Sanderson, MD

Sentara Neuroscience Institute

Recruiting

Virginia Beach, Virginia, United States, 23456

Contacts

Jennifer Kennedy

JMKENNE2@sentara.com

Principal Investigator:

John Agola, MD

Swedish Neurosciences Research

Recruiting

Seattle, Washington, United States, 98122

Contacts

Carol Kemp

Carol.Kemp@swedish.org

Caryl Tongco

Caryl.Tongco@swedish.org

Principal Investigator:

Stephen Monteith, MD

Aurora Research Institute

Recruiting

Milwaukee, Wisconsin, United States, 53233

Contacts

Jennifer Mathieu

Jennifer.Mathieu@aurora.org

Principal Investigator:

Akram Shhadeh, MD

CHUM - Hôpital Notre-Dame Hospital

Recruiting

Montreal, Quebec, Canada, QC H2L 4M1

Contacts

Suzanne Nolet

Suzanne.Nolet@crchum.qc.ca

Principal Investigator:

Jean Raymond, MD

University of Saskatchewan

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

Contacts

Lilian Urroz

lilian.urroz@usask.ca

Principal Investigator:

Michael Kelly, MD

More Information

Sponsor

University of Virginia

Last update posted

Aug 18, 2016

Last verified

Aug, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Virginia on 2016-08-18.