Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System

Summary

This is a prospective, double-blinded, randomized, placebo-controlled, multi-center, pivotal clinical study in which subjects are evaluated for prevention of major limb amputation in the treatment of non-reconstructable Rutherford Category 5 critical limb ischemia (CLI). Subjects will be randomized in 3:1 ratio (device treatment: placebo-control).

Timeline

Start

2017-01

Primary completion

2018-12

Completion

2019-03

Drugs

Indications