To evaluate the safety and effectiveness of direct carotid access for stenting using
the Neuroguard IEP® Direct System in subjects at elevated risk for adverse events
following carotid endarterectomy (CEA).

The purpose of this registry is to collect safety data in patients undergoing aortic aneurysm repair, peripheral vascular intervention, hemodialysis access intervention or peripheral embolization with an eligible Medtronic market-released product(s), including but not limited to balloon catheters, peripheral or carotid stents, stet grafts, and coils, in a real-world setting.

The types of balloons being studied in this clinical study is similar to other balloon devices that are routinely used in angioplasty procedures; however, it has a unique technology inside the balloon which is designed to deliver sonic energy (sound) to disrupt the hard, calcified elements of vascular blockages. With the balloon inflated at a low pressure, the probe will be activated to disrupt the calcium that is restricting the expansion of the artery.

The purpose of this study is to observe the safety and effectiveness of the Indigo Aspiration System. This study will help determine how study participants recover when the study device is used to remove the clot from the deep veins.