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Intracranial AneurysmsULTRANCT02657772

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

An observational study of Intracranial Aneurysms, run by University of Maryland, Baltimore at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Intracranial Aneurysms
How many people
100 participants
Where
6 sitesUnited States
Study dates
Nov 2013to Mar 2021
How long will I take part?
18 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 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • Patient is between 18 and 80 years of age (inclusive).
  • 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.
  • Target® Ultra coils may be used.
  • 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.
  • 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.
  • Patient (or patient's legally authorized representative) has provided written informed consent.
  • Patient is willing and able to comply with protocol follow-up requirements.

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University of Maryland Baltimore

    Baltimore, Maryland, 21201

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287

  • Geisinger medical center

    Danville, Pennsylvania, 17822

  • WellStar Research Institute

    Marietta, Georgia, 30060

  • Christiana Care Health System

    Newark, Delaware, 19718

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Keywords
Target Ultra coils, small aneurysms
Medical subject headings
Intracranial Aneurysm

What is being measured

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

  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.

    Measured: 9-18 months from baseline/procedure date

Secondary outcomes (3)

  1. Residual Aneurysm assessment using modified Raymond Scale

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

    Measured: 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.

    Measured: 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

    Measured: Procedure

Timeline

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

  1. First posted18 Jan 2016 (estimated)
  2. Study startNov 2013
  3. Primary completionMar 2021
  4. Study completionMar 2021

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
100 participants (actual)
Target duration
18 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02657772
Sponsor's protocol ID
HP-00055046
Acronym
ULTRA
Status last verified
Mar 2022
First submitted
14 Jan 2016
Last updated
8 Mar 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
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.

Publications

  • Jindal G, Almardawi R, Gupta R, Colby GP, Schirmer CM, Satti SR, Pukenas B, Hui FK, Caplan J, Miller T, Cherian J, Aldrich F, Kibria G, Simard JM; ULTRA Study Investigators. Target Ultra and Nano coils in the endovascular treatment of small intracranial aneurysms (ULTRA Registry). J Neurosurg. 2022 Jun 24;138(1):233-240. doi: 10.3171/2022.5.JNS2296. Print 2023 Jan 1.

    PubMed 35901755

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Aneurysms, run by University of Maryland, Baltimore at 6 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 13 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: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Aneurysm Recurrence (TAR) (time frame: 9-18 months from baseline/procedure date). 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 NCT02657772, 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 8 Mar 2022.

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