TARGET Intracranial Aneurysm Coiling Registry

NCT01748903 | Unknown DMC

• 1 other identifier: 19180
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this prospective registry is to collect real world, post-marketing data on the use of Stryker Target® 360,Target® 2D, and 2nd generation Target® Nano coils for the embolization of ruptured or unruptured intracranial saccular aneurysms. Up to 300 patients (150 in the TARGET 360°/Helical arm and 150 in the New NANO arm) presenting with intracranial aneurysms suitable for coil embolization will be enrolled at up to 20 sites. A post hoc analysis comparing Target® 360° and Target® 2D coil technical and clinical endpoints will be performed.

Conditions

Intracranial Aneurysms

Keywords

intracranial aneurysm; cerebral aneurysm; packing density; Target Coils; aneurysm embolization

Outcome Measures

Primary Outcomes (1)

• Packing Density

  Packing density will be calculated based on aneurysm volume and amount of coil used during the embolization procedure.

  At immediate post-procedure (Day 1)

Secondary Outcomes (12)

• Occlusion Rate

  At immediate post-procedure (Day 1) and 3-9 month follow-up

• Aneurysm Re-access Rate

  At end of study procedure (Day 1)

• Time of Fluoroscopic Exposure

  At immediate post-procedure (Day 1)

• Overall Procedure Time

  At Immediate post-procedure (Day 1)

• Aneurysm Recurrence

  3-9 month follow-up

Study Arms (1)

Target 360°, 2D, Nano Coils

Subjects will undergo embolization using Target 360°, 2D, Nano Coils for the treatment of their intracranial aneurysm.

Device: Target 360°, 2D Coils, Nano Coils

Interventions

Target 360°, 2D Coils, Nano Coils DEVICE

Also known as: Target coils, Target Nano coil

Target 360°, 2D, Nano Coils

Eligibility Criteria

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

Study Population

All sequential patients presenting with unruptured and ruptured saccular aneurysms, who meet all eligibility criteria, will be considered for study enrollment.

You may qualify if:

• Patient is 18 years or older.
• Patient has a documented, previously untreated, saccular intracranial aneurysm, unruptured or ruptured, suitable for embolization with coils.
• (NEW NANO arm ONLY) Target aneurysm is ≤7mm.
• Patient has a Hunt and Hess Score of 3 or less.
• Patient has a premorbid mRS of 3 or less.
• Patient or patient's legally authorized representative has provided written informed consent.
• Patient is willing to and can comply with study follow-up requirements.

You may not qualify if:

• Patient is \< 18 years old.
• Dissecting aneurysm.
• Patients with intracranial aneurysms (other than the target aneurysm) that will require treatment during the study period (enrollment through follow-up).
• Patients in whom the target aneurysm will be treated with coils other than Stryker Target® 360°, Target® Helical coils, and 2nd generation Target® Nano Coils.
• (NEW NANO Arm ONLY) Patients in whom the target aneurysm was treated with a total coil length comprised of \<25% Stryker Target® 2nd generation Nano Coils.
• Target aneurysm is fusiform.
• Patients in which the target aneurysm cannot be coiled in one procedure (i.e. staged procedure)

Sponsors & Collaborators

• Mercy Health Ohio: lead
• Stryker Neurovascular: collaborator

Study Sites (9)

University of Arizona

Phoenix, Arizona, 85006, United States

RECRUITING

Tallahassee Neurological Clinic

Tallahassee, Florida, 32308, United States

RECRUITING

Presence Saint Joseph Medical Center

Joliet, Illinois, 60435, United States

RECRUITING

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

RECRUITING

McLaren Health

Flint, Michigan, 48532, United States

RECRUITING

SSM DePaul Health Center

St Louis, Missouri, 63132, United States

RECRUITING

Mercy Health St. Vincent Medical Center

Toledo, Ohio, 43604, United States

RECRUITING

Greenville Health System

Greenville, South Carolina, 29605, United States

RECRUITING

West Virginia University Hospital

Morgantown, West Virginia, 26505, United States

RECRUITING

Related Publications (1)

• Zaidat OO, Castonguay AC, Rai AT, Badruddin A, Mack WJ, Alshekhlee AK, Shah QA, Hussain SI, Kabbani MR, Bulsara KR, Taqi AM, Janardhan V, Patterson MS, Nordhaus BL, Elijovich L, Puri AS. TARGET(R) Intracranial Aneurysm Coiling Prospective Multicenter Registry: Final Analysis of Peri-Procedural and Long-Term Safety and Efficacy Results. Front Neurol. 2019 Jul 9;10:737. doi: 10.3389/fneur.2019.00737. eCollection 2019.

  PMID: 31338061 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

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

Study Officials

• Osama O Zaidat, MD, MS

  Mercy Health St. Vincent Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria J Calderon, MPH

CONTACT

4192514367; vcalderon@mercy.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Neuroscience and Stroke Programs

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 13, 2012
• Study Start: February 1, 2013
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2019
• Last Updated: July 24, 2018

Record last verified: 2018-07

Locations

US (9)