Framing Eighteen Coils in Cerebral Aneurysms Trial

NCT01655784 | Completed DMC

• 1 other identifier: 120439
• Study Type: interventional
• Target: 651
• Locations: 1 country
• Sites: 24

Brief Summary

This trial is being conducted in order to compare angiographic outcomes in patients receiving 0.014-0.0155" platinum framing and filling coils (larger diameter coils) versus those treated solely with coils less than 0.014" (with a standard diameter). Hypothesis: Angiographic occlusion at follow-up imaging will be more frequent in patients receiving 0.014-0.0155" platinum coils during embolization compared to those receiving smaller-diameter coils.

Conditions

Cerebral Aneurysm

Keywords

aneurysm; intracranial aneurysm; cerebral aneurysm; intracranial embolization; aneurysm embolization; intracranial coil; eighteen coils; bare platinum coils; GDC Coil; Target Coil

Outcome Measures

Primary Outcomes (1)

• Occlusion Rate

  Occlusion rate: Angiographic occlusion, improvement or no change in the post-coiling appearance of the aneurysm as judged by an independent core lab on follow-up angiography at 12-18 months after endovascular embolization.

  12-18 Month Follow-up

Secondary Outcomes (6)

• Morbidity

  Entire Study Duration (from signed research consent until 12-18 month follow-up complete)

• Packing Density

  Post-Procedure (images taken during the procedure immediately after the coils are placed will be assessed)

• Clinical Outcome

  3-6 Month Follow-up and 12-18 Month Follow-up

• Re-hemorrhage and Re-treatment Rates

  3-6 Month Follow-up and 12-18 Month Follow-up

• Mortality

  Entire Study Duration (from study procedure until 12-18 month follow-up)

Study Arms (2)

Eighteen Coils (0.014-0.0155 inch)

ACTIVE COMPARATOR

Subjects who randomize to this arm will receive larger diameter bare platinum coils for treatment of their cerebral aneurysm. Subjects in this arm could receive a combination of the following protocol approved intracranial coils depending on the phase: Target XL 360 Standard, Target XL 360 Soft, Target XL 360 Helical, GDC-18 360 Standard, GDC-18 3D, GDC-18 2D, GDC-18 Soft, and/or 0.014-0.0155 inch diameter bare platinum intracranial coils.

Procedure: Coil Embolization with larger Diameter Coils

Standard Coils (0.014 inch)

ACTIVE COMPARATOR

Subjects who randomize to this arm will receive the standard diameter bare platinum coils for treatment of their cerebral aneurysm. Subjects in this arm could receive a combination of the following protocol approved intracranial coils depending on the phase: Target 360 Standard, Target 360 Soft, Target 360 Ultra, Target 360 NANO, Target 360 Helical Ultra, GDC-10 360 Standard SR, GDC-10 360 Soft SR, GDC-10 UltraSoft, GDC-10 3D, GDC-10 2D, GDC-10 Soft 2D SR, GDC-10 Soft SR, GDC-10 Soft, and/or any additional 0.014 inch or less diameter bare platinum intracranial coils.

Procedure: Coil Embolization with Standard Diameter Coils

Interventions

Coil Embolization with larger Diameter Coils PROCEDURE

Eighteen Coils placed in cerebral aneurysm

Also known as: Eighteen Coils, Cerebral Aneurysm Embolization, Aneurysm Coils

Eighteen Coils (0.014-0.0155 inch)

Coil Embolization with Standard Diameter Coils PROCEDURE

Cerebral aneurysms will be embolized with standard diameter coils.

Also known as: Eighteen Coils, Cerebral Aneurysm Embolization, Aneurysm Coils

Standard Coils (0.014 inch)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient presenting with ruptured or unruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular treating team (neurointerventionist and/or neurosurgeon).
• The neurointerventionist feels that the aneurysm can be safely treated with either using, or not using, a 0.015-0.0155" platinum coil.
• Patients are 18-80 years of age (inclusive).
• Patient must be Hunt and Hess grade 0 to 3.
• Patient has given fully informed consent to endovascular coiling procedure. If the patient cannot consent for themselves, appropriate written consent has been sought from their next of kin or appropriate power of attorney.
• Aneurysm 6-14 mm in maximum diameter.
• Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography or MRA) at 3-6 months and 12-18 months after endovascular treatment.
• The patient has not been previously randomized into this trial or another related ongoing trial.
• The aneurysm has not been previously treated by coiling or clipping.

You may not qualify if:

• Target aneurysm has had previous coil treatment or has been surgically clipped.
• Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage.
• Inability to obtain informed consent.
• Medical or surgical co-morbidity such that the patient's life expectancy is less than 2 years.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Stryker Neurovascular: collaborator

Study Sites (24)

UCSF-Fresno, Community Regional Medical Center

Fresno, California, 93701, United States

Location

Radiology Imaging Associates

Englewood, Colorado, 80112, United States

Location

Colorado Neurological Institute

Englewood, Colorado, 80113, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

University of South Florida - Tampa General

Tampa, Florida, 33606, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

University of Massachusetts Medical School

North Worcester, Massachusetts, 01655, United States

Location

University of Mississippi

Jackson, Mississippi, 39216, United States

Location

University of Buffalo

Buffalo, New York, 14203, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Mayfield Clinic

Cincinnati, Ohio, 45219, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Medical Center of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health

Greenville, South Carolina, 29615, United States

Location

Tennessee Interventional Associates - Erlanger

Chattanooga, Tennessee, 37403, United States

Location

Fort Sanders Regional Medical Center

Knoxville, Tennessee, 37916, United States

Location

University of Tennessee Medical Center - Knoxville

Knoxville, Tennessee, 37920, United States

Location

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

University of Texas - Southwestern

Dallas, Texas, 75390, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

Related Links

• Vanderbilt University Medical Center-Department of Neurological Surgery

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

• J D Mocco, MD, MS

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: August 2, 2012
• Study Start: December 4, 2012
• Primary Completion: February 19, 2024
• Study Completion: February 19, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

US (24)