Clinical Evaluations of Intravascular Lithotripsy (IVL) Technology
Enrollment was completed in December 2015. The study demonstrated compelling safety and performance results with the IVL System. Treatment resulted in a low residual stenosis. 6 month data is now available.
A total of 334 subjects (167 per treatment arm) will be enrolled in the study with procedural success being defined as residual stenosis <30% prior to DCB or stenting by angiographic core lab. Enrollment began in April 2017 and is expected to be completed in April 2020.
In addition to the randomized study, an observational study of subjects who do not meet the inclusion/exclusion criteria for the randomized study will be conducted. A maximum of 250 subjects at the same 50 sites will be enrolled in the observational study. Procedural success defined as residual stenosis <30% prior to DCB or stenting by angiographic core lab. Enrollment in the observational study is anticipated to last approximately 16 months. Subjects in the observational study will be followed through hospital discharge.
The performance endpoint, was defined as acute reduction in residual diameter stenosis. The 30-day, 6 month, and 12 month secondary endpoints include the ability of the Shockwave IVL System to achieve a post-shockwave residual diameter stenosis of ≤50%.
Enrollment was completed in July, 2017. The study demonstrated compelling safety and performance results with the IVL System. 30-day data is now available.