CAD III

MAKING BIG WAVES
IN COMPLEX CALCIUM

LARGEST & MOST RIGOROUS SHOCKWAVE STUDY
Showcases Safety, Effectiveness & Ease of Use of Coronary IVL
DISRUPT CAD III Co-PI Dr. Jonathan Hill
Presents the CAD III Primary Endpoint Results
JACC Publication
JACC
CAD III JACC PUBLICATION
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TCT Data Slides
TCT DATA SLIDES
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DISRUPT CAD III Q&A
With Co-PI Dr. Jonathan Hill
JACC
Dr. Jonathan Hill, M.D.
Royal Brompton Hospital London, United Kingdom
JACC READ BLOG POST

Key Findings

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
device

CAD III By The Numbers

DOWNLOAD CAD III HIGHLIGHTS
384
Patients at
47 Sites
100%
Severe Ca++
47.9mm
Calcium Length
98%
IVL Crossing & Therapy
Delivery
99%
Stent Delivery
0.3%
Final Major
Dissections
0.3%
Final Perforations
0.3%
Abrupt Closure
0%
Slow Flow/No Reflow
11.9%
Residual Stenosis
1.7mm
Acute Gain

DISRUPT CAD III OCT Sub-Study Provides New Insights on IVL’s Unique MOA that Facilitates Optimal Stent Delivery, Expansion and Apposition

Richard Schlofmitz
Watch Dr. Shlofmitz Present the DISRUPT CAD III OCT Sub-Study Results
Watch the Presentation
OCT Sub-Study Slides Thumbnail
Review the Full OCT Sub-Study Slides in Detail Download CAD III OCT Slides
CAD III OCT Sub-Study:
Top 10 Data Points to Know Download CAD III INFOGRAPHIC

DISRUPT CAD III Design & Patient Demographics

Stable angina, unstable angina or silent ischemia
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Heavily calcified, de novo coronary lesions RVD 2.5 – 4.0 mm, stenosis ≥50%, Lesion length ≤40 mm

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

Baseline Characteristics:

71 yo

40% DM

3.0mm RVD

65% DS

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

angriographic outcomes

Low Rates of Complications, Similar to DISRUPT CAD I & II

angriographic outcomes

Low Rates of MACE, Mostly Driven by In-Hospital NQWMI

angriographic outcomes
For use outside the U.S. only. Caution: In the United States, Shockwave C2 Coronary IVL catheters are investigational devices, limited by United States law to investigational use. Shockwave C2 Coronary IVL catheters are commercially available in certain countries outside the U.S. Please contact your local Shockwave representative for specific country availability. The Shockwave C2 Coronary IVL catheters are indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic de novo coronary arteries prior to stenting. Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events. Contact Shockwave Medical at customerservice@shockwavemedical.com

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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.

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