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| Name | Class |
|---|---|
| Stryker Neurovascular | INDUSTRY |
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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.
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
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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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9-18 months from baseline/procedure date |
| Measure | Description | Time Frame |
|---|---|---|
| Residual Aneurysm assessment using modified Raymond Scale | Residual Aneurysm assessment using modified Raymond Scale (complete occlusion, minimal residual, residual aneurysm) | 9-18 months from baseline/procedure date |
| Modified Rankin Scale |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Gaurav Jindal, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Care Health System | Newark | Delaware | 19718 | United States | ||
| WellStar Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35901755 | Derived | 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. |
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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.
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Assess the disability or degree of dependence of participants with Modified Rankin Scale score \
| Baseline, 1 Day post procedure, 3- 28 days post procedure, 3-9 months, 9-18 months from baseline/procedure date |
| Technical procedural success | Technical procedural success defined as the successful delivery and deployment of Ultra® coils in the target aneurysm | Procedure |
| 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 |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |