Clinical trial NCT02657772: Ultra Coils From Start to Finish for the Endovascular Repair of Small Intracranial Aneurysms
Official title: Ultra Coils From Start to Finish for the Endovascular Repair of Small Intracranial Aneurysms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysms
Keywords: Target Ultra coils
small aneurysms
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Stryker Neurovascular
First posted: 2016-01-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Target Aneurysm Recurrence (TAR)
timeFrame: 9-18 months from baseline/procedure date
Secondary outcomes:
measure: Residual Aneurysm assessment using modified Raymond Scale
timeFrame: 9-18 months from baseline/procedure date
measure: Modified Rankin Scale
timeFrame: Baseline, 1 Day post procedure, 3- 28 days post procedure, 3-9 months, 9-18 months from baseline/procedure date
measure: Technical procedural success
timeFrame: Procedure
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Marietta
country: United States
facility: WellStar Research Institute
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Danville
country: United States
facility: Geisinger medical center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Maryland, Baltimore
name: Gaurav Jindal, MD
role: PRINCIPAL_INVESTIGATOR
References: