DISRUPT PAD II

Core lab adjudicated, long-term, multi-center study exclusively enrolling heavily calcified lesions building upon DISRUPT PAD I. Designed to assess the safety and performance of Shockwave IVL as stand-alone treatment among eight centers in Europe and New Zealand in 2015. 

DISRUPT PAD II logo
DISRUPT PAD II logo

Study Leadership

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

  • Marianne Brodmann, MD
    Co-Principal Investigator Division of Internal Medicine Medical University Graz, Graz, Austria
  • Thomas Zeller, MD 
    Co-Principal Investigator Universitäts-Herz-Zentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany

PAD II Study Details 

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 60
    Patients with heavily calcified femoral-popliteal lesions
  • 85
    %
    Severe calcification by PARC¹†
  • 98
     mm
    Average calcified length
  • 12
    Month follow-up

1: Brodmann M et al, Primary outcomes and mechanism of action of Intravascular Lithotripsy in calcified, femoropopliteal lesions: Results of DISRUPT PAD II, Catheter Cardiovasc Interv. 2018
†PARC: Peripheral Academic Research Consortium

Compelling Safety & Performance in Severely Calcified Lesions*

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 0
    %
    Perforations, embolization, thrombus, no reflow, abrupt closure
  • 1.7
    %
    Dissection (D/E/F)**, provisional stenting
  • 24
    %
    Residual stenosis with average acute gain of 3.0 mm, average balloon inflation pressure of 6 atm after Shockwave IVL therapy
  • 100
    %
    Procedural success, low use of adjunctive tools
  • 79
    %
    Freedom from clinically-driven target lesion revascularization (CD-TLR) at one year, with simple revascularization procedures

*Core Lab and Clinical Events Committee (CEC) adjudicated
**Guidewire induced through recanalization of a chronic total occlusion resolved with stent placement 

Patients Who Were Treated with Optimal Technique Had Less Than 9% CD–TLR At 12-Months 

Bar chart displaying improved primary patency and CD-TLR rates with optimal technique.

 

Balloon Sizing and Therapeutic Overlap Enables Optimal Energy Delivery to Peripheral Calcified Lesions 

Illustration showing optimal vs. undersized balloon sizing and coverage. The left side depicts an 'Optimal' balloon fully apposed to the vessel wall, improving energy transfer, while an 'Undersized' balloon shows gaps, reducing efficiency.

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