DISRUPT PAD III Randomized Clinical Trial

Shockwave Intravascular Lithotripsy (IVL) provides superior vessel prep and excellent long-term results in calcified vessels while preserving future treatment options.

DISRUPT PAD III RCT logo
DISRUPT PAD III Randomized Clinical Trial logo

DISRUPT PAD III: The Largest-ever Randomized Study of Severely Calcified Peripheral Lesions 

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 45
    Global sites
  • 306
    Superficial femoral artery (SFA)/popliteal lesions randomized to Shockwave IVL or percutaneous transluminal angioplasty (PTA)
  • 83
    %
    Severe calcification by Peripheral Academic Research Consortium (PARC), an independent core lab*
  • 129 mm
    Average calcified length by an independent core lab*

*Data refers to Shockwave IVL arm of randomized study 

Accordion Section

Shockwave IVL’s unique mechanism of action (MOA) delivers significantly more luminal gain with lower dilatation pressure and less need for post-dilatation. 

Bar and icon graph illustrating superior procedural success and atraumatic treatment outcomes between Intravascular Lithotripsy (IVL) and Percutaneous Transluminal Angioplasty (PTA).

Shockwave IVL maintains control of the procedure by minimizing complications such as dissections, embolization and perforations. Shockwave IVL significantly reduces the need for bailout stents, preserving future treatment options. 

Three-part infographic showing the clinical benefits of Intravascular Lithotripsy (IVL) compared to Percutaneous Transluminal Angioplasty (PTA) in terms of reduced dissections, lower complications, and reduced bailout stenting.

Embolic protection: Utilized in 1.3% of cases in Shockwave IVL treatment arm.

Provisional stent: Utilized if residual stenosis ≥50% by visual estimate or unresolved ≥ type D dissection, and trans-lesional gradient > 10 mmHg.

Shockwave IVL has demonstrated excellent patency out to two years in a severely calcified patient population. 

Line graph comparing primary patency rates over 24 months for two treatment groups after an index procedure.

Number of subjects at risk: 

Shockwave IVL  131  120 107 88 83
PTA  136 107 95 75 66

*Primary patency defined as freedom from provisional stenting at index procedure, freedom from clinically-driven target lesion revascularization, and freedom from restenosis determined by duplex ultrasound. 

Intravascular Lithotripsy for Peripheral Artery Calcification: Disrupt PAD III RCT Mid-Term Outcomes

DISRUPT PAD III RCT Mid-Term Outcomes

Watch Dr. Bill Gray and Dr. Sahil Parikh discuss the significance of the PAD III RCT one- and two-year results.

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 II
    Core lab adjudicated, long-term, multi-center study exclusively enrolling heavily calcified lesions building upon DISRUPT PAD I.
    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