DISRUPT CAD III
A study to evaluate the safety and effectiveness of the Shockwave Coronary IVL System(*) in de novo, calcified, stenotic, coronary arteries prior to stenting.
*This device is approved for investigational use only in the U.S.
This is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Coronary IVL System in de novo, calcified, stenotic, coronary arteries prior to stenting.
"Current treatment for deep calcium in coronary and peripheral arteries is suboptimal with today's technology. Cardiologists and vascular physicians are seeing more and more patients with calcified disease, particularly elderly patients or those with diabetes and chronic kidney disease. The Shockwave device being evaluated in this trial uses intravascular lithotripsy, a similar therapy used to break up kidney stones, and could prove to safely dilate deep calcium." says Robert Stoler, MD, principal investigator.
Please contact the research coordinator for the exclusions: Emily Laible, RN, BSN, CCRC, at 214-820-9903 or email at Emily.Laible@BSWHealth.org.
Additional information may be found for this study, DISRUPT CAD III, at:
Robert M. Stoler, MD, FACC, FSCAI
For more information, please contact: Emily Laible, RN, BSN, CCRC, at 214-820-9903 or email at Emily.Laible@BSWHealth.org.