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

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.

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.