DISRUPT CAD III

Shockwave’s pivotal study demonstrating the safety, effectiveness and ease of use of Shockwave coronary Intravascular Lithotripsy (IVL).

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DISRUPT CAD III logo
DISRUPT CAD III logo

Study leadership

This section contains attributions including profile pictures, titles, descriptions, and Twitter handles.

  • Jonathan Hill, MD
    Co-Principal Investigator, Consultant Cardiologist Kings College Hospital, London, UK
  • Dean Kereiakes, MD, FACC, FSCAI
    Co-Principal Investigator, Medical Director The Christ Hospital Heart and Vascular Center, Cincinatti, OH

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 384
    Patients
  • 47
    Sites
  • 100
    %
    Severe Ca++
  • 47.9
     mm
    Calcium length
  • 98
    %
    Shockwave 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
  • 1.7
     mm
    Acute gain

Key Findings

CAD III confirms Shockwave IVL safety with low rates of major peri-procedural clinical and angiographic complications, setting a new bar for safety in complex calcified coronary lesions. 

  • 92.2% of patients were free from major adverse cardiovascular events (MACE) at 30 days, a composite of cardiac death (CD) (0.5%), myocardial infarction (MI) (7.3%), or target vessel revascularization (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 Shockwave 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%) and without in-hospital MACE (93%) 
  • Successful Shockwave IVL crossing and therapy delivery in 98% of lesions, correlating to 99% stent delivery 
  • 1.7 mm acute gain and 11.9% final in-stent residual stenosis 

CAD III demonstrated Shockwave coronary IVL’s ease of use and quick learning curve to achieve consistently predictable outcomes. 

  • MACE, procedural success and device crossing success were similar between roll-in procedures (first case for each site) and procedures included in the pivotal analysis (taken from the DISRUPT CAD III publication)

Study Design and Patient Characteristics

Objective   

Prospective, multicenter, single-arm global investigational device exemption (IDE) to evaluate the safety and effectiveness of Shockwave coronary IVL 

Primary Safety Endpoint   

Freedom from MACE (cardiac death, myocardial infarction or target vessel revascularization)  at 30 days  

Primary Effectiveness Endpoint 

Successful stent delivery with residual stenosis <50% and without in-hospital MACE     

Secondary Performance Endpoint   

Clinical and angiographic success 

Patient Characteristics Summary   

  • 71 years old  
  • 40% diabetes mellitus (DM) 
  • 3.0 mm right ventricular systolic dysfunction (RVD) 
  • 65% diameter stenosis 
  • 48 mm Ca++ length 
  • 26 mm lesion length 
  • 57% LAD, 13% LCS, 29% RCA, 1% LM 
  • 292 Ca++ arc at max Ca++ site 
  • 0.96 mm thick Ca++ at max Ca++ site 
Stable angina, unstable angina or silent ischemia 
Heavily calcified, de novo coronary lesions RVD 2.5 – 4.0 mm, stenosis ≥50%, Lesion length ≤40 mm

Accordion Section

Dr. Jonathan Hill, Co-Principal Investigator, Presents Primary Endpoint Analysis of DISRUPT CAD III

Dr. Jonathan Hill Presents the CAD III Primary Endpoint Results

Dr. Jonathan Hill discusses the effectiveness of Intravascular Lithotripsy for the treatment of severely calcified coronary artery disease.

DISRUPT CAD III Resources

See All Clinical Evidence
See All Clinical Evidence
  • DISRUPT CAD I
    Single-arm, pre-market study demonstrating the safety and performance of Shockwave IVL in heavily calcified  coronary lesions.
    Coronary IVL
  • DISRUPT CAD II
    European post-market study confirming DISRUPT CAD I results and showing strong safety and procedural success with Shockwave coronary IVL.
    Coronary IVL
  • DISRUPT CAD IV
    Shockwave coronary study demonstrating the safety and effectiveness of Shockwave IVL within a Japanese patient population.
    Coronary IVL

Dr. Hill is a paid consultant for Shockwave Medical.