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Intracranial AneurysmsTARGETNCT01748903

TARGET Intracranial Aneurysm Coiling Registry

An observational study of Intracranial Aneurysms, run by Mercy Health Ohio at 9 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracranial Aneurysms
What is being tested?
Target 360°, 2D Coils, Nano Coils
Type of treatment
Medical device
How many people
150 participants
Where
9 sitesUnited States
Study dates
Feb 2013to Mar 2019
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

9 sites in 1 country.

Victoria J Calderon, MPH contact

4192514367

vcalderon@mercy.com

9 sites in 1 country

United States9 sites, 9 recruiting

  • McLaren Health

    Flint, Michigan, 48532

    Aniel Q Majjhoo, MD

    Bharath R Naravetla, MD

    Recruiting

  • Greenville Health System

    Greenville, South Carolina, 29605

    Mahmoud Rayes, MD

    Recruiting

  • Presence Saint Joseph Medical Center

    Joliet, Illinois, 60435

    Aamir Badruddin, MD

    Recruiting

  • West Virginia University Hospital

    Morgantown, West Virginia, 26505

    Ansaar Rai, MD

    Recruiting

  • University of Arizona

    Phoenix, Arizona, 85006

    Peter J Sunenshine, MD

    Recruiting

  • SSM DePaul Health Center

    St Louis, Missouri, 63132

    Amer Alshekhlee, MD

    Richard Callison, MD

    Recruiting

  • Tallahassee Neurological Clinic

    Tallahassee, Florida, 32308

    Matthew Lawson, MD

    Narlin Beaty, MD

    Recruiting

  • Mercy Health St. Vincent Medical Center

    Toledo, Ohio, 43604

    Victoria J Calderon, MPH, 419-251-4367, vcalderon@mercy.com

    Osama O Zaidat, MD, MS

    Recruiting

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

    Ajit Puri, MD

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
Target 360°, 2D Coils, Nano Coils
Keywords
intracranial aneurysm, cerebral aneurysm, packing density, Target Coils, aneurysm embolization
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Target 360°, 2D Coils, Nano CoilsDevice

    Also called Target coils, Target Nano coil

Study groups in NCT01748903
Study groupRoleWhat they receive
Target 360°, 2D, Nano CoilsSubjects will undergo embolization using Target 360°, 2D, Nano Coils for the treatment of their intracranial aneurysm.
Receives: Device: Target 360°, 2D Coils, Nano Coils

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Packing Density

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

    Measured: At immediate post-procedure (Day 1)

Secondary outcomes (12)

  1. Occlusion Rate

    Angiographic occlusion of the aneurysm will be adjudicated by an independent core lab using immediate post-procedure and 3-9 month follow-up angiography.

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

  2. Aneurysm Re-access Rate

    The rate of re-assess (Microcatheter kick-back rate) of the target aneurysm will be captured during the procedure.

    Measured: At end of study procedure (Day 1)

  3. Time of Fluoroscopic Exposure

    Total time of fluoroscopic exposure will be captured from the initial recording of the road map to the final angiogram after completion of the coil embolization procedure.

    Measured: At immediate post-procedure (Day 1)

  4. Overall Procedure Time

    The overall procedure time will be captured from the time of guide catheter placement to the end of the coil embolization procedure.

    Measured: At Immediate post-procedure (Day 1)

  5. Aneurysm Recurrence

    Measured: 3-9 month follow-up

  6. Aneurysm Re-treatment Rate

    Aneurysm re-treatment rates will be tracked and recorded during the 3-9 month follow-up

    Measured: 3-9 month follow-up

  7. Aneurysm Bleed and Re-bleed Rate

    Aneurysm Bleed and Re-bleed Rate will be assessed and recorded at the 3-9 month follow-up.

    Measured: 3-9 month follow-up

  8. Treatment-related Morbidity and Mortality

    Treatment-related morbidity and morality will be tracked and recorded from study procedure through the 3-9 month follow-up.

    Measured: from study procedure (Day 1) to 3-9 month follow-up

  9. Modified Rankin Score

    Modified Rankin score will be recorded at baseline, hospital discharge, and during the 3-9 month follow-up.

    Measured: At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up

  10. Device-related serious adverse events

    Procedural and post-procedural serious adverse events related to the device and/or procedure will be captured and recorded at the end of the procedure and until the patient has completed the 3-9 month follow-up.

    Measured: From the study procedure (Day 1) until 3-9 month follow up

  11. Length of hospital stay

    Length of hospital stay will be recorded at the time of patient discharge.

    Measured: At hospital discharge (Day 3)

  12. Technical and clinical endpoints of Target 360° and 2D coils

    A post hoc analysis comparing Target 360° and 2D coil primary and secondary technical and clinical endpoints will be performed upon final data analysis.

    Measured: 3-9 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2012 (estimated)
  2. Study startFeb 2013
  3. Primary completionJan 2019 (estimated)
  4. Study completionMar 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT01748903
Sponsor's protocol ID
19180
Acronym
TARGET
Status last verified
Jul 2018
First submitted
7 Dec 2012
Last updated
24 Jul 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31338061

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Aneurysms, run by Mercy Health Ohio at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Victoria J Calderon, MPH (4192514367, vcalderon@mercy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Packing Density (time frame: At immediate post-procedure (Day 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01748903, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.

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