Clinical trial NCT01748903: TARGET Intracranial Aneurysm Coiling Registry
Official title: TARGET Intracranial Aneurysm Coiling Registry: A Prospective Clinical Efficacy and Safety Study of Stryker Target® 360°, Target® Helical, and 2nd Generation Target® Nano Coils
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Aneurysms
Keywords: intracranial aneurysm
cerebral aneurysm
packing density
Target Coils
aneurysm embolization
Lead sponsor: Mercy Health Ohio
Sponsor class: OTHER
Collaborators: name: Stryker Neurovascular
First posted: 2012-12-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patient is \< 18 years old.
2. Dissecting aneurysm.
3. Patients with intracranial aneurysms (other than the target aneurysm) that will require treatment during the study period (enrollment through follow-up).
4. 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.
5. (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.
6. Target aneurysm is fusiform.
7. Patients in which the target aneurysm cannot be coiled in one procedure (i.e. staged procedure)

Primary outcomes:
measure: Packing Density
timeFrame: At immediate post-procedure (Day 1)
Secondary outcomes:
measure: Occlusion Rate
timeFrame: At immediate post-procedure (Day 1) and 3-9 month follow-up
measure: Aneurysm Re-access Rate
timeFrame: At end of study procedure (Day 1)
measure: Time of Fluoroscopic Exposure
timeFrame: At immediate post-procedure (Day 1)
measure: Overall Procedure Time
timeFrame: At Immediate post-procedure (Day 1)
measure: Aneurysm Recurrence
timeFrame: 3-9 month follow-up
measure: Aneurysm Re-treatment Rate
timeFrame: 3-9 month follow-up
measure: Aneurysm Bleed and Re-bleed Rate
timeFrame: 3-9 month follow-up
measure: Treatment-related Morbidity and Mortality
timeFrame: from study procedure (Day 1) to 3-9 month follow-up
measure: Modified Rankin Score
timeFrame: At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up
measure: Device-related serious adverse events
timeFrame: From the study procedure (Day 1) until 3-9 month follow up
measure: Length of hospital stay
timeFrame: At hospital discharge (Day 3)
measure: Technical and clinical endpoints of Target 360° and 2D coils
timeFrame: 3-9 month follow-up
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: University of Arizona
state: Arizona
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic
state: Florida
city: Joliet
country: United States
facility: Presence Saint Joseph Medical Center
state: Illinois
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Flint
country: United States
facility: McLaren Health
state: Michigan
city: Saint Louis
country: United States
facility: SSM DePaul Health Center
state: Missouri
city: Toledo
country: United States
facility: Mercy Health St. Vincent Medical Center
state: Ohio
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
Study officials:
affiliation: Mercy Health St. Vincent Medical Center
name: Osama O Zaidat, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.