CClinicalTrials.gg
CompletedNCT02657772ULTRAUpdated Mar 8, 2022

Ultra Coils From Start to Finish for the Endovascular Repair of Small Intracranial Aneurysms

An observational study in Intracranial Aneurysms, sponsored by University of Maryland, Baltimore. Completed at 6 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-08.

Sponsored by University of Maryland, Baltimore · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to assess the safety and efficacy rates of the treatment of small intracranial aneurysms with Stryker Neurovascular's Target® 360 Ultra coils which are a type of platinum coils used to occlude aneurysms.

Read the detailed description

This is a Prospective single-arm multi-center Registry which aims to collect data to determine the safety and efficacy of one of these marketed coils, namely the Target® 360 Ultra coils. This is not an intervention or treatment study. Up to 100 subjects at up to 6 sites will be enrolled.

Study Procedure

  1. Screening and Informed consent: Patients will undergoing endovascular treatment of intracranial aneurysm will be screened using the Eligibility criteria checklist, and enrolled using approved Institutional Informed Consent process and approved Informed Consent form.
  2. Baseline assessment: This involves standard of care history, medical examinations and laboratory assessments prior to coiling procedure.
  3. Coiling procedure
  4. One day post procedure assessment
  5. 3- 28 days post procedure assessment
  6. 3-9 months post procedure assessment
  7. 9-18 months post procedure assessment

The Site investigator and/or co-investigator or their representative(s) will conduct training before initiating the study to develop a common understanding of the clinical protocol, Case Report Forms, and study procedures among the investigators and site research staff. Regulatory binders with study protocol, training documents, and standard operating guidelines will be provided for each study site. The Principal investigator and/or co-investigator shall confirm data received is accurate by reviewing with the provider collecting the data. The principle investigator and/or co-investigator will approve all data received. Additionally, OpenClinica, a web-based data capture service, will receive all Case Report Forms.

Study Monitoring will be electronic requiring upload of de-identified source documents through provided secure channels. However on site visits maybe scheduled in advance with the site personnel. Audits may be also be performed for quality assurance.

02

Conditions studied

  • Intracranial Aneurysms

Keywords

  • Target Ultra coils
  • small aneurysms
03

In context

Intracranial Aneurysm

427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.

This study's enrollment of 100 is below the median of 200 across 198 observational studies indexed under Intracranial Aneurysm.

Browse Intracranial Aneurysm studies →

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients will be between 18 and 80 years of age (inclusive)and have a documented untreated intracranial aneurysm, less than or equal to 5 mm, ruptured or unruptured, for which Ultra® coils are treatment options, and for which primary coiling treatment is planned to be completed during a single procedure (i.e., no "staged" treatment). Preliminary intracranial stent placement and/or use of an intracranial endoluminal balloon device as adjunctive therapy is allowed.

Inclusion criteria

  1. Patient is between 18 and 80 years of age (inclusive).
  2. Patient has a documented untreated intracranial aneurysm less than or equal to 5.0 mm in maximal dimension, ruptured or unruptured, suitable for embolization with coils.
  3. Target® Ultra coils may be used.
  4. Target aneurysm can be completely or nearly completely coiled at index procedure (No staged treatment procedures) without anticipated need for any target aneurysm reintervention after 72 hours of the index procedure. If a stent is to be placed during a separate preliminary procedure, then screening and enrollment for the coiling procedure must take place after the stenting procedure is completed.
  5. Target aneurysm morphology allows for adequate retention of coils within the aneurysmal sac without occlusion of the parent artery, as determined by the treating physician.
  6. Patient (or patient's legally authorized representative) has provided written informed consent.
  7. Patient is willing and able to comply with protocol follow-up requirements.

Exclusion criteria

Exclusion Criteria:

  1. Patient is \<18 or >80 years old.
  2. Target aneurysm is felt by the physician operator to be mycotic or clearly dissecting in etiology.
  3. Target aneurysm is >5.0 mm maximum luminal dimension.
  4. Target aneurysm has been previously treated by surgery or endovascular therapy.
  5. Target aneurysm is in the physician's estimation unlikely to be successfully treated by endovascular techniques.
  6. Patient presents as Hunt and Hess grade V for a ruptured aneurysm.
  7. Patient has known hypersensitivity to platinum, tungsten, nickel, stainless steel or structurally related compounds found in Target® Ultra coils.
  8. Patients who have had or could have a severe reaction to contrast agents that cannot be adequately pre-medicated prior to the coiling procedure.
  9. Patients who are unable to complete scheduled follow up assessments at the enrolling center due to limited life expectancy (\<24 months), comorbidities or geographical considerations.
  10. Patients with Moya-Moya disease, brain arteriovenous malformation(s), significant atherosclerotic stenosis, tortuousity or other conditions preventing access to the target aneurysm.
  11. Target aneurysm with significant thrombosis that may increase the likelihood of recanalization at the discretion on the investigator.
  12. Female patient has a positive pregnancy assessment at baseline, breastfeeding patient, or patient who plans to become pregnant within the 18 months following coiling.
  13. The following comorbidities that may confound results: (a) organ failure of kidney (b) uncorrectable coagulation abnormality.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Target follow-up
18 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Target Aneurysm Recurrence (TAR)

    Target Aneurysm Recurrence (TAR) - defined as clinically relevant recurrence resulting in: target aneurysm re-intervention, rupture/re-rupture, and/or death from unknown cause as assessed at 9-18 months post procedure.

    Time frame: 9-18 months from baseline/procedure date

Secondary outcomes

  1. Residual Aneurysm assessment using modified Raymond Scale

    Residual Aneurysm assessment using modified Raymond Scale (complete occlusion, minimal residual, residual aneurysm)

    Time frame: 9-18 months from baseline/procedure date

  2. Modified Rankin Scale

    Assess the disability or degree of dependence of participants with Modified Rankin Scale score \</=2 to determine good clinical outcomes at 9-18 months. It is compared with baseline values.

    Time frame: Baseline, 1 Day post procedure, 3- 28 days post procedure, 3-9 months, 9-18 months from baseline/procedure date

  3. Technical procedural success

    Technical procedural success defined as the successful delivery and deployment of Ultra® coils in the target aneurysm

    Time frame: Procedure

07

Study locations

6 sites
  • Christiana Care Health System
    Newark, Delaware 19718, United States
  • WellStar Research Institute
    Marietta, Georgia 30060, United States
  • University of Maryland Baltimore
    Baltimore, Maryland 21201, United States
  • Johns Hopkins University School of Medicine
    Baltimore, Maryland 21287, United States
  • Geisinger medical center
    Danville, Pennsylvania 17822, United States
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

References and documents

Individual participant data

Plan to share: No — The enrolled subjects will be assigned a unique research code that will not be associated with any identifiable information. All health information will be de-identified.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02657772
Lead sponsor
University of Maryland, Baltimore
Collaborators
Stryker Neurovascular
Responsible party
Gaurav Jindal (Assistant Professor of Radiology, Neurosurgery, Neurology, University of Maryland, Baltimore) — Principal investigator
First posted
Jan 18, 2016
Start date
Nov 2013
Primary completion
Mar 2021
Completion
Mar 2021
Last update
Mar 8, 2022

Study contacts

Gaurav Jindal, MD
principal investigator · University of Maryland, Baltimore

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion