DISRUPT PAD III Observational Study

The largest prospective real-world evidence for the treatment of complex, heavily calcified peripheral artery disease (PAD).

DISRUPT PAD III OS logo
DISRUPT PAD III Observational Study logo

DISRUPT PAD III Observational Study (OS)

  • Objective

    Assess real-world peri-procedural outcomes of Shockwave Intravascular Lithotripsy (IVL) for treatment of calcified, stenotic, peripheral arteries

  • Design

    Prospective, multicenter, single-blind, observational study

  • Key inclusion

    Rutherford classification 2-6. Moderate-severe calcification* ilio-femoral, femoral, popliteal and infrapopliteal arteries

*Presence of fluoroscopic evidence of calcification by PARC definition: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50 mm in length; or extending for minimum of 20 mm if lesion is <50 mm in length 

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 1,373
    Patients
  • 1,677
    Lesions
  • 30
    Sites
  • 3
    Countries

Armstrong E, VIVA Late Breaking Clinical Trial 2022 

Complex Real-World Patients 

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 1,373
    Patients
  • 36
    %
    Critical Limb Ischemia (CLI) patients
  • 56
    %
    Diabetes Mellitus
  • 27
    %
    Renal Insufficiency

Challenging Lesions 

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 1,531
    Lesions
  • 90
    %
    Moderate-severe calcium*
  • 115
     mm
    Average calcified length
  • 31
    %
    Chronic Total Occlusions (CTOs)

*PARC Definition
Armstrong E, VIVA Late Breaking Clinical Trial 2022 

Predictable Outcomes in Challenging Situations

Predictably consistent results across vessel beds, challenging lesions and complex patients 

MAJORITY OF STENOSIS REDUCTION FROM IVL TREATMENT

Bar chart showing diameter stenosis percentages across various categories before the procedure (Pre-procedure), after Intravascular Lithotripsy (Post-IVL), and at the final measurement (Final). The chart is divided into three main sections: 'Vessel Beds,' 'Challenging Lesions,' and 'Complex Patients.'

 
Armstrong E, Late Breaking Clinical Trial and Shockwave-Sponsored Symposium, VIVA 2022 

Shockwave IVL Procedural Insights

Use of adjunctive technology was at the operator’s discretion; use of embolic protection was less when Shockwave IVL was used as the only calcium modification tool; Shockwave IVL saw better results with appropriate Shockwave IVL sizing. 

When Shockwave IVL was used as the only calcium modification therapy*, there was less use of embolic protection. 

Comparison graphic illustrating embolic protection percentages with and without adjunctive calcium-modifying therapy during intravascular lithotripsy (IVL).

Per a multivariable analysis, proper Shockwave IVL balloon sizing (≥ 1:1)** is an independent predictor of improved stenosis reduction but not a predictor of complications. 

Illustration comparing balloon-to-artery ratio in intravascular procedures.

*Ca modifying therapy: atherectomy and/or scoring/cutting balloon
**PAD OS data analysis is consistent with prior PAD II data analysis and continues to support 1.1:1 sizing in the product instructions for use (IFU)
Armstrong E, VIVA Late Breaking Clinical Trial 2022 

Real-World Outcomes Consistent with Randomized Trial

Shockwave IVL safely and effectively modifies calcium across multiple vessel beds. 

FINAL ANGIOGRAPHIC COMPLICATIONS (CORE LAB)

DISRUPT PAD III RCT1  DISRUPT PAD III OS2 
N 153  1,367 
Vessels  Superficial femoral artery (SFA)/popliteal  Iliac, common femoral artery (CFA), SFA/popliteal, infrapopliteal 
Dissection (Type D-F)  0%  0.7% 
Perforation  0%  0.2% 
Embolization  0%  0% 
Slow flow/no reflow  0%  0% 
Abrupt closer  0%  0% 
Thrombus   0%  0% 

Proven Effective Calcium Modification 

1: Tepe et al, J Am Coll Cardiol Intv 2021
2: E. Armstrong, VIVA Late Breaking Clinical Trial 2022 

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 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