MAPS Trial: Matrix And Platinum Science

The endovascular treatment of intracranial aneurysms has become an accepted alternative to
surgical repair given the many recent advances with neurointerventional devices and
procedures. The introduction of GDC coils in 1993 provided physicians and their patients a
less invasive treatment option. Additionally, the results of two large international trials,
ISAT and ISUIA, have shown the benefits of endovascular treatment over surgery for treatment
of specific types of aneurysms. One limitation of endovascular coil embolization is aneurysm
recurrence or recanalization which is not infrequently observed angiographically at follow
up. Aneurysm recanalization may be a result of aneurysm morphology, anatomic location and
flow orientation, aneurysm regrowth or the degree of coil compaction. Despite the widespread
adoption of endovascular aneurysm coiling, there remains much to be learned about the
efficacy and optimization of this treatment modality.

The goal of endovascular embolization of intracranial aneurysms is to prevent rupture or
re-rupture. Fortunately, the incidence of aneurysm rupture following coil embolization is
very low. Follow-up angiographic analysis to evaluate the occlusion and stability of the
treated aneurysm provides a surrogate endpoint against which to weigh the likelihood of
rupture/re-rupture. However, angiographic interpretation is subjective, operator dependent
and can be influenced by multiple confounding variables.

The MAPS trial will examine Target Aneurysm Recurrence Rates: clinically relevant recurrence
rates resulting in target aneurysm reintervention, rupture/re-rupture and/or death from an
unknown cause for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular
aneurysms. The trial will compare TAR rates to recurrences measured by angiographic analysis
and assess the utility of angiographic analysis for predicting clinically relevant
recurrences.

Inclusion Criteria:

1. Patient is between 18 and 80 years of age (inclusive).

2. Patient has a documented untreated intracranial saccular aneurysm 4-20 mm diameter
angiographic lumen, ruptured or unruptured, suitable for embolization with coils.

3. Both GDC® Coils and Matrix 2® Coils (Every attempt should be made to treat with as
much randomized coil type as possible to achieve optimal occlusion.) are treatment
options (all shapes allowed with exception of GDC VortX Coil).

4. Target aneurysm can be adequately coiled at index procedure (NO staged coiling
procedures). If a Neuroform 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 for centers in the United
States) 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 not saccular in nature (mycotic, fusiform, dissecting).

3. Target aneurysm is > 20 mm maximum luminal dimension, < 4 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 IV or V for a ruptured aneurysm.

7. Patient presents with Modified Rankin Score 4 or 5 at baseline.

8. Patient is concurrently enrolled in another investigational drug or device study
unless permission is granted by the sponsor.

9. Patient has known hypersensitivity to Polyglycolic Polylactic Acid (PGLA), platinum,
nickel, stainless steel or structurally related compounds found in Matrix 2® Coils
and/or GDC® Coils.

10. Patients who have had or could have a severe reaction to contrast agents that cannot
be adequately pre-medicated prior to the coiling procedure.

11. Patients who are unable to complete scheduled follow up assessments at the enrolling
center due to limited life expectancy (< 12 months), comorbidities or geographical
considerations.

12. Planned use of adjunctive therapy stents except Neuroform is not allowed.

13. Patients with Moya-Moya disease, AVMs, AV fistula, intracranial tumors, intracranial
hematoma (unrelated to target aneurysm), significant atherosclerotic stenosis,
tortuousity or other conditions preventing access to the target aneurysm.

14. Patients with multiple aneurysms.

15. Target aneurysm with significant thrombosis that may increase the likelihood of
recanalization at the discretion of the investigator.

16. Female patient has a positive pregnancy assessment at baseline.