DISRUPT PAD III OBSERVATIONAL STUDY

Design

Assess 'real-world' peri-procedural outcomes of IVL for treatment of calcified, stenotic, peripheral arteries

Prospective, Multicenter, Single-Blind, Observational Study

RC 2-6
Moderate-severe calcification*
Ilio-femoral, femoral, popliteal and infrapopliteal arteries

1,373

Patients

1,677

Lesions

Sites

Countries

* 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 ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length

Armstrong E, VIVA Late Breaking Clinical Trial 2022

Complex Real-World Patients and Lesions

Complex Patients

1,373 Patients

36%

CLI Patients

56%

Diabetes Mellitus

27%

Renal Insufficiency

Challenging Lesions

1,531 Lesions

90%

Mod-Severe CA++^†

115mm

Avg. Calcified Length

31%

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

chart demonstrating the consistent efficacy of IVL

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

IVL Procedural Insights

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

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

1.3% Embolic protection when IVL was used without adjunctive Ca modifying therapy 1.3% embolic protection when IVL was used without adjunctive therapy

1.3% embolic protection when IVL was used without adjunctive therapy

vs.

20% Embolic protection when IVL was used with adjunctive Ca modifying therapy 20% embolic protection when IVL was used with adjunctive therapy

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

IVL Balloon to Artery Ratio