Ultra Coils From Start to Finish for the Endovascular Repair of Small Intracranial Aneurysms (ULTRA)
|ClinicalTrials.gov Identifier: NCT02657772|
Recruitment Status : Active, not recruiting
First Posted : January 18, 2016
Last Update Posted : July 7, 2020
|Condition or disease|
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.
- 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.
- Baseline assessment: This involves standard of care history, medical examinations and laboratory assessments prior to coiling procedure.
- Coiling procedure
- One day post procedure assessment
- 3- 28 days post procedure assessment
- 3-9 months post procedure assessment
- 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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|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 :||September 2020|
|Estimated Study Completion Date :||September 2020|
- 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.
- 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)
- 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.
- Technical procedural success [ Time Frame: Procedure ]Technical procedural success defined as the successful delivery and deployment of Ultra® coils in the target aneurysm
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657772
|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|
|Principal Investigator:||Gaurav Jindal, MD||University of Maryland, Baltimore|