Study ID: Disrupt CAD III
Researchers seek patients who have been diagnosed with calcified lesion(s) of the coronary arteries for a study on the safety and efficacy of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) system.
Intravascular lithotripsy is an innovative technology that generates sonic pressure waves that safely pass through the soft tissue, only impacting the hardened calcified plaque inside the artery wall by creating a series of micro-fractures. After the calcium has been weakened, the artery can be opened and blood flow restored with the placement of a cardiac stent. All patients in the study will undergo this treatment with catheterization.
Participants are followed through discharge. Phone follow-up with trial participants will be conducted at 30 days, and six, 12 and 24 months.
This is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting.
The Coronary IVL System consists of an IVL balloon catheter with two integrated pairs of lithotripsy emitters, a lithotripsy generator and connector cable.
Eligible patients must present with stable, unstable or silent ischemia and be deemed suitable for percutaneous coronary intervention. The target lesion must not have been previously treated with any interventional procedure.
Other inclusion/exclusion criteria apply.
- Must have been diagnosed with heavily calcified lesions in a coronary artery