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.