DISRUPT CAD II

European post-market study confirming DISRUPT CAD I results and showing strong safety and procedural success with Shockwave coronary Intravascular Lithotripsy (IVL).

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DISRUPT CAD II logo
DISRUPT CAD II logo

Study Leadership

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  • Prof. Jean Fajadet
    Co-Principal Investigator Clinique Pasteur, Toulouse, France
  • Prof. Carlo di Mario
    Co-Principal Investigator AOU Careggi SOD Interventistica Firenze, Italy

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 120
    Patients
  • 15
    Hospitals
  • 94
    %
    Severe Ca++
  • 100
    %
    Successful delivery of Shockwave IVL
  • 100
    %
    Successful delivery of stents
  • 0
    %
    Severe dissections
  • 0
    %
    Perforations
  • 0
    %
    Slow/no reflow

Study Design and Patient Characteristics

Objective  

A post-market study to assess the safety and performance of the coronary Shockwave IVL system with more patients in more centers 

Primary Safety Endpoint  

In-hospital major adverse cardiovascular event (MACE) (cardiac death, myocardial infarction or target vessel revascularization) 

Secondary Performance Endpoint  

Clinical and angiographic success 

Patient Characteristics Summary  

  • 72 years old 
  • 32% diabetes mellitus (DM) 
  • 3.0 mm reference vessel diameter (RVD) 
  • 60% diameter stenosis 
  • 26 mm Ca++ length 
  • 72% concentric/28% eccentric lesions 
  • 30% side branch involvement 
Stable angina, unstable angina or silent ischemia
Heavily calcified, de novo coronary lesions RVD 2.5 – 4.0 mm, stenosis ≥50%, lesion length ≤32 mm 

Countries Included in Study

  • Flag of Belgium Belgium
  • Flag of Denmark Denmark
  • Flag of France France
  • Flag of Germany Germany
  • Flag of Italy Italy
  • Flag of Netherlands Netherlands
  • Flag of Spain Spain
  • Flag of Sweden Sweden
  • Flag of United Kingdom United Kingdom

Strong Performance and Safety with Low Complications

Accordion Section

OCT Case Example: Proximal Left Anterior Descending Artery (LAD) with Side Branch Involvement

  • Severe Ca++: >270° and >1 mm thick 
  • Ca++ fractures: Multiple locations (white arrows) 
  • Final result: Full stent expansion large acute gain 

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 III
    Largest and most rigorous Shockwave study showcasing the safety, effectiveness and ease of use of 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