CAD III confirms IVL safety with low rates of major peri-procedural clinical and angiographic complications, setting a new bar for safety in complex coronary lesions.
92.2% of patients were free from MACE at 30 days, a composite of CD (0.5%), MI (7.3%), or TVR (1.6%)
- Primary MACE driver was in-hospital non-Q-wave MI (5.7%)
- Low risk of perforation (0.3%), major dissection (0.3%), abrupt closure (0.3%), and slow flow/no reflow (0.0%) at the end of procedure
CAD III showcases IVL effectiveness with large lumen gains that facilitate stent delivery and optimize stent expansion.
- 92.4% procedural success rate, defined as successful stent delivery (99%) residual stenosis <50% (100%), & without in-hospital MACE (93%)
- Successful IVL crossing & therapy delivery in 98% of lesions, correlating to 99% stent delivery
- 1.7mm acute gain and 11.9% final in-stent residual stenosis
CAD III demonstrated Coronary IVL’s ease of use and quick learning curve to achieve consistently predictable outcomes.
- Despite >80% of operators having no prior experience with IVL, MACE, procedural success and device crossing success were similar between first roll-in first case and pivotal cohort
CAD III By The NumbersDOWNLOAD CAD III HIGHLIGHTS
DISRUPT CAD III OCT Sub-Study Provides New Insights on IVL’s Unique MOA that Facilitates Optimal Stent Delivery, Expansion and Apposition
DISRUPT CAD III Design & Patient Demographics
Objective: Prospective, multicenter, single-arm global IDE to evaluate the safety and effectiveness of coronary IVL
Primary Safety Endpoint: Freedom from MACE at 30 days
- Cardiac death, Myocardial infarction, or Target vessel revascularization
Primary Effectiveness Endpoint: Procedural success
- Successful stent delivery with residual stenosis <50% and without in-hospital MACE
Secondary Performance Endpoints: Clinical and Angiographic Success
48mm Ca++ Length
25mm Lesion Length
57% LAD, 13% LCX, 29% RCA, 1% LM
292 Ca++Arc @ Max Ca++ Site
.96mm Thick Ca++ @ Max Ca++ Site
Large Circumferential Lumen Gains to Facilitate Stent Delivery, Apposition & Expansion
Low Rates of Complications, Similar to DISRUPT CAD I & II
Low Rates of MACE, Mostly Driven by In-Hospital NQWMI
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A link to the publication entitled “Intravascular lithotripsy for treatment of severely calcified coronary artery disease: The Disrupt CAD III study” is provided below for your reference. Please note the results discussed in this publication pertain to the use of intravascular lithotripsy (IVL) in de novo calcified coronary target lesions. The device and its use in coronary arteries is not approved by the U.S. Food and Drug Administration (FDA).Click Here to Access the JACC Publication on the JACC Website
As a member of the Medical Device Manufacturers Association (“MDMA”), Shockwave Medical, Inc. strictly adheres to the requirements of the MDMA Code of Conduct Interactions with Health Care Providers. The author financial interests in Shockwave Medical, Inc. are summarized in the publication.
Possible adverse effects are consistent with standard catheter-based cardiac interventions, include, but are not limited to, the following: abrupt vessel closure, allergic reaction to contrast medium, anticoagulant and/or antithrombotic therapy, aneurysm, arrhythmia, arteriovenous fistula, bleeding complications, cardiac tamponade or pericardial effusion, cardiopulmonary arrest, cerebrovascular accident (CVA), coronary artery/vessel occlusion, perforation, rupture or dissection, coronary artery spasm, death, emboli (air, tissue, thrombus or atherosclerotic emboli), emergency or non-emergency coronary artery bypass surgery, emergency or non-emergency percutaneous coronary intervention, entry site complications, fracture of the guide wire or failure/malfunction of any component of the device that may or may not lead to device embolism, dissection, serious injury or surgical intervention, hematoma at the vascular access site(s), hemorrhage, hypertension/hypotension, infection/sepsis/fever, myocardial Infarction, myocardial ischemia or unstable angina, pain, peripheral Ischemia, pseudoaneurysm, renal failure/insufficiency, restenosis of the treated coronary artery leading to revascularization, shock/pulmonary edema, slow flow, no reflow, or abrupt closure of coronary artery, stroke, thrombus, vessel closure, abrupt, vessel injury requiring surgical repair, or vessel dissection, perforation, rupture, or spasm.
In addition, patients may be exposed to other risks associated with coronary interventional procedures, including risks from conscious sedation and local anesthetic, the radiographic contrast agents used during angiography, the drugs given to manage the subject during the procedure, and the radiation exposure from fluoroscopy.