Principal Investigator
Morris Mosseri MD

Sponsor
Cardialysis

Abstract
The SPLASH trial is a prospective, multi-center, double-blind randomized trial. It will compare the safety and effectiveness of PharmaSonics' Sonotherapy treated in-stent restenotic lesions of native coronary arteries to those treated with sham. The purpose is to evaluate the long-term safety and clinical efficacy of PharmaSonics'UrxTM Intravascular Sonotherapy (IST) in patients who meet specific eligibility criteria.

The primary endpoint is to demonstrate the long-term safety and effectiveness of IST by demonstrating a 30% reduction in the MACE rates of IST vs sham treated in-stent restenotic lesions in native coronary arteries at 9 months post procedure. The secondary endpoints include a measure of binary restenosis as determined in the 500 patient QCA cohort and a reduction in intimal hyperplasia volume as determined in the IVUS cohort, as well as long term safety and procedural success.

Status
Initiating