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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02657772
Recruitment Status : Active, not recruiting
First Posted : January 18, 2016
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Stryker Neurovascular
Information provided by (Responsible Party):
Gaurav Jindal, University of Maryland, College Park

Brief 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.

Condition or disease
Intracranial Aneurysms

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: Ultra Coils From Start to Finish for the Endovascular Repair of Small Intracranial Aneurysms
Actual Study Start Date : November 2013
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Target Aneurysm Recurrence (TAR) [ Time Frame: 9-18 months from baseline/procedure date ]
    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.


Secondary Outcome Measures :
  1. Residual Aneurysm assessment using modified Raymond Scale [ Time Frame: 9-18 months from baseline/procedure date ]
    Residual Aneurysm assessment using modified Raymond Scale (complete occlusion, minimal residual, residual aneurysm)

  2. Modified Rankin Scale [ Time Frame: Baseline, 1 Day post procedure, 3- 28 days post procedure, 3-9 months, 9-18 months from baseline/procedure date ]
    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.

  3. Technical procedural success [ Time Frame: Procedure ]
    Technical procedural success defined as the successful delivery and deployment of Ultra® coils in the target aneurysm



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657772


Locations
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United States, Delaware
Christiana Care Health System
Newark, Delaware, United States, 19718
United States, Georgia
WellStar Research Institute
Marietta, Georgia, United States, 30060
United States, Maryland
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
United States, Pennsylvania
Geisinger medical center
Danville, Pennsylvania, United States, 17822
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Maryland, College Park
Stryker Neurovascular
Investigators
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Principal Investigator: Gaurav Jindal, MD University of Maryland, College Park

Additional Information:

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Responsible Party: Gaurav Jindal, Assistant Professor of Radiology, Neurosurgery, Neurology, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT02657772     History of Changes
Other Study ID Numbers: HP-00055046
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

Keywords provided by Gaurav Jindal, University of Maryland, College Park:
Target Ultra coils
small aneurysms

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases