The (PFLEX) study was a prospective, single-arm, multicenter study for the treatment of unruptured IAs using the Pipeline™ Shield.
The primary endpoint was a major stroke in the territory supplied by the treated artery or neurologic death at 1-year post-procedure. Also, angiographic outcomes were assessed by an independent radiology laboratory at 6 months and 1 year.

Fifty patients with 50 unruptured IAs were treated. At 1-year post-procedure, no major strokes or neurologic deaths were reported, and complete occlusion was achieved in 81.8% of subjects.

There were no instances of aneurysm recurrence or retreatment. There were 6 cases of in-stent stenosis; all were asymptomatic
and non-serious.

Conclusion:
The angiographic and safety outcomes corroborate previous evidence that the Pipeline™ Shield is a safe and effective treatment for Intracranial Aneurysms.

The SHIELD study assessed the performance of the Pipeline™ Flex Embolization Device with Shield Technology™ in subjects undergoing treatment for intracranial aneurysms in a large
real-world, post-market setting.

The primary effectiveness endpoint (complete occlusion without significant parent artery stenosis (≤ 50% stenosis) or retreatment of the target aneurysm through 1 year post-procedure) and the primary safety endpoint (occurrence of major stroke in the territory supplied by the treated artery or neurological death through 1 year post-procedure) were met in all populations. In addition there was no aneurysm recurrence through the 1-year follow-up and no target aneurysm rupture at peri-procedure.

Conclusion:
The results of the SHIELD study demonstrate that the benefits of aneurysm treatment with the Pipeline™ Shield device outweigh the risk associated with the procedure in all studied populations.

PREMIER was the first prospective, multicenter trial to evaluate the use of the Pipeline™ device for the treatment of small and medium, unruptured aneurysms of the intracranial carotid and proximal vertebral artery. The study was conducted in 1 Canadian and 22 US centers. A total of 141 subjects with 141 target aneurysms were treated in the study.

Subject follow-up rates were high, with 98.6% (139/141) of subjects completing the 1-year clinical follow. Complete aneurysm occlusion without significant parent artery stenosis (≤ 50%) or retreatment of the target aneurysm 1-year post-procedure (primary effectiveness endpoint) occurred in 76.71% of subjects.

A total of 81.9% (113/138) aneurysms had complete occlusion, none (0%; 0/138) had aneurysm recurrence and 2.9% (4/139) had aneurysm retreatment at the 1-year follow-up.

Occurrence of major stroke in the territory supplied by the treated artery or neurological death at 1-year post-procedure (primary safety endpoint) occurred in 2.17% of subjects.

There were no major strokes in the territory supplied by the treated artery or neurological death at 30 days post-procedure due to procedural complications. Delayed intracerebral hemorrhage >30 days through 1-year post-procedure occurred in 0.73% of subjects. The overall mortality rate was 0.7% (1/141).

Conclusion:
Overall, a high rate of complete aneurysm occlusion was achieved with the use of the Pipeline™ device in the treatment of small/medium-sized wide-necked aneurysms. The incidence of major stroke, neurological death, and delayed intracerebral hemorrhage in the PREMIER study were low.

Therefore, results from the PREMIER Study demonstrated that the Pipeline™ device is effective and safe for the endovascular treatment of unruptured, small and medium, wide-necked intracranial aneurysms in the intracranial carotid and proximal vertebral artery.

The PUFs study evaluated the safety and effectiveness of the Pipeline™ device in large and giant, wide-necked intracranial aneurysms in the ICA.

107of the 108 enrolled subjects were treated with the Pipeline™ device. A total of 104 subjects with 106 aneurysms were included in the primary effectiveness cohort.

At 6-months, 73.6% of aneurysms achieved complete occlusion without major stenosis.

At 1-year, 86.8% were completely occluded, which increased through 3-years to 93.4% and 5-years to 95.2%.

There were no cases of aneurysm recurrence throughout the
five-year follow-up period.

The primary safety endpoint was the occurrence of ipsilateral major stroke or neurologic death at 6-months post-procedure, which occurred in 5.6% of subjects. No additional events of ipsilateral major stroke or neurological death were reported between 6-month and 5-year follow-up; therefore, the overall rate of ipsilateral major stroke or neurologic death remained 5.6%.

Conclusion:
Pipeline™ offers a safe and effective treatment of large or giant intracranial internal carotid artery aneurysms, demonstrated by high rates of complete aneurysm occlusion and low rates of
adverse neurologic events; even in aneurysms failing previous alternative treatments.

The purpose of the ADVANCE study is to assess the safety and effectiveness of the Pipeline™ Vantage Embolization Device with Shield Technology™ in the treatment of intracranial aneurysms within the intended indication for use.

Primary Safety Endpoint: Incidence of major stroke in the territory supplied by the treated artery or neurological death at 1-year post-procedure.

Primary Effectiveness Endpoint: Incidence of complete aneurysm occlusion (Raymond Roy Scale Class 1) without significant parent artery stenosis (≤ 50%) or retreatment of the target aneurysm at 1 year post-procedure.