DISRUPT BTK

Post-market, European study to assess the safety and performance of Shockwave Intravascular Lithotripsy (IVL) as a standalone therapy in heavily calcified infrapopliteal lesions out to 30 days.

DISRUPT BTK logo
DISRUPT BTK logo

Study Leadership

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

  • Marianne Brodmann, MD
    Medical University Graz, Austria 
  • Andrew Holden, MD
    Auckland City Hospital, Auckland, New Zealand
  • Thomas Zeller, MD
    Universitäts-Herzzentrum Freiberg-Bad Krozingen, Bad Krozingen, Germany

Study Design and Patient Characteristics

Objective 

Post-market, European study to assess the safety and performance of Shockwave IVL as standalone therapy in heavily calcified infrapopliteal lesions out to 30 days.

 

Primary Safety Endpoint 

Composite of major adverse events (MAE), defined as death, myocardial infarction, need for emergency surgical revascularization of the target limb, or amputation of the target limb. 

 

Secondary Endpoint 

Procedural success, defined as the ability of the Shockwave peripheral IVL system to achieve ≤50% residual diameter stenosis. 

Patient Characteristics Summary 

  •  20 patients from three sites
  •  100% moderately/severely calcified lesions
  • 75% Rutherford Category 5
>50% infrapopliteal stenosis <150 mm long, a target vessel diameter of 2.5 to 3.5 mm, Rutherford category 3 to 5 ischemia, and moderate to severe calcification
100% freedom from clinically driven target lesion revascularization (CD TLR) at 30 days, 0% MAE at 30 days

Countries Included in Study 

  • Flag of Austria Austria
  • Flag of Germany Germany
  • Flag of New Zealand New Zealand

*Core Lab & CEC adjudicated. 

Compelling Safety and Performance in Severely Calcified Lesions 

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 95
    %
    Procedural success
  • 0
    %
    Perforations, embolization, slow/no reflow, abrupt closure
  • 26
    %
    Final residual stenosis with an acute gain of 1.5 mm
  • 0
    %
    Major adverse event at 30 days

*Core Lab & CEC adjudicated. 

See All Clinical Evidence
See All Clinical Evidence
  • DISRUPT BTK II
    Global prospective, multi-center, single-arm study assessing the safety and effectiveness of Shockwave peripheral IVL in treating long, calcified BTK lesions.
    Peripheral IVL
  • DISRUPT PAD III Randomized Clinical Trial
    The largest-ever randomized clinical study of Shockwave peripheral IVL treatment in severely calcified peripheral lesions, out to 24 months.
    Peripheral IVL
  • DISRUPT PAD III Observational Study
    The largest prospective real-world evidence for the treatment of complex, heavily calcified peripheral arterial disease (PAD).
    Peripheral IVL