DISRUPT BTK II CLTI Cohort Analysis

Establishing a new benchmark for patients with CLTI: New data confirm Shockwave IVL’s continued impact on patients with CLTI at 24 months. DISRUPT BTK II assessed the continued safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of calcified, stenotic lesions in below-the-knee (BTK) arteries. This sub-analysis focuses on results from the patients with CLTI enrolled in the study.

DISRUPT BTK II CLTI Cohort Analysis logo

CLTI Cohort Key Findings

  • Establishing a new benchmark in CLTI

    Shockwave IVL delivers outcomes, out to two years, that set a new benchmark for success in the minimally invasive treatment of patients with CLTI with calcified BTK lesions.

  • Demonstrating clinical durability

    DISRUPT BTK II 24-month outcomes show continued durability of Shockwave IVL for calcified BTK treatment, demonstrating sustained clinical benefit in a complex CLTI population.

  • Reinforcing Shockwave IVL as a frontline strategy

    The 24-month outcomes further establish Shockwave IVL as a frontline calcium modification strategy for patients with complex BTK lesions.

Chandra V, Two-Year Outcomes from the Disrupt PAD BTK II Study. VIVA. Las Vegas, NV; 2026.

DISRUPT BTK II Study Design

Objective 

Assess the continued safety and effectiveness of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic lesions in BTK arteries. Products included Shockwave M5+ and Shockwave S4.

Key Inclusion Criteria

  • Rutherford classification (RC) 3-5, RC 3 capped at 20% of enrolled patients 
  • Moderate-severe calcification* 
  • Up to two BTK lesions ≤ 200 mm in length 

Primary Safety Endpoint 

Major adverse limb events (MALE) or post-operative death (POD) at 30 days

Primary Effectiveness Endpoint 

Procedural success, defined as ≤ 50% residual stenosis for all treated target lesions without serious angiographic complications 

Additional analysis to include lesions with ≤ 30% residual stenosis without angiographic complications 

Independent Clinical Events Committee (CEC), Angiographic Core Laboratory, and Duplex Ultrasound Core Laboratory

DISRUPT BTK II, the largest prospective study of real-world, complex patients with moderate to severe calcified BTK disease, now demonstrates durable outcomes through 24 months.
No other calcium modification technology has been evaluated in a population this challenging, setting Shockwave IVL as a benchmark for CLTI care.

*Presence of fluoroscopic evidence of calcification by PARC (Peripheral Academic Research Consortium) 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. 

DISRUPT BTK II
DISRUPT BTK II

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 250
    Patients
  • 305
    Lesions
  • 38
    Global sites
  • 2
    Year follow-up

Chandra V, Two-Year Outcomes from the Disrupt PAD BTK II Study. VIVA. Las Vegas, NV; 2026.

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 200
    Patients
  • 245
    Lesions

CLTI Cohort Baseline Demographics

Rutherford Category

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 71
    %
    RC 5, minor tissue loss2*
  • 29
    %
    RC 4, ischemic rest pain2**

Medical History

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 73
    %
    Patients had wounds at baseline2
  • 18
    %
    Hemodialysis-dependent1
  • 77
    %
    Diabetes mellitus1

Lesions

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 86
    %
    Moderate-severe Ca++1†
  • 80
    mm
    Mean lesion length1
  • 31
    %
    Chronic total occlusions (CTOs)1

1: Armstrong E, One-Year Outcomes from the Disrupt PAD BTK II Study. VIVA. Las Vegas, NV; 2025.
2: Based on analysis of the CLTI cohort enrolled in the BTK II study.
*Per limb 143/201 | **Per limb 59/201 | †PARC Definition

Results and conclusion

Clinical Procedural Insights in a CLTI Cohort

In a challenging patient cohort, IVL was shown to be a safe and effective treatment of challenging calcific BTK lesions with minimal need for provisional stenting.

CONFIRMED SAFETY

Total Serious Angiographic Complications Post-IVL2 Total Serious Angiographic Complications at Final1
2.3% 1.3%

 

CONFIRMED EFFECTIVENESS

 Average Residual Stenosis Post-IVL2 Average Residual Stenosis at Final1
30.0% 25.7%

 

MINIMAL PROVISIONAL STENTING

Stent/Tack Implant Total2 Provisional Stent/Tack Implant2
5.7% 2.8%*

*Remaining Stent/Tack implants were part of physicians’ standard algorithm.
1: Armstrong E, One-Year Outcomes from the Disrupt PAD BTK II Study. VIVA. Las Vegas, NV; 2025.
2: Based on analysis of the CLTI cohort enrolled in the BTK II study.

Freedom from CD-TLR at 24 Months

24-month outcomes confirm the durability of Shockwave IVL’s clinical outcomes in complex calcified BTK disease.

Rutherford Category Freedom from CD-TLR at 24 Months
Full Cohort (n=250) 81.0%1
RC 3 (n=50) 87.3%1
CLTI Cohort (n=200) 79.2%1
RC 4 (n=57) 79.6%2
RC 5 (n=143) 79.3%2

1: Chandra V, Two-Year Outcomes from the Disrupt PAD BTK II Study. VIVA. Las Vegas, NV; 2026.
2: Data on file at Shockwave Medical.
Clinically driven target revascularization (CD-TLR).
Kaplan Meier (KM) is an analysis that uses probability to capture patients lost to follow-up.
Freedom from CD-TLR analysis excluded patients with above the ankle amputation of target limb.

 

Freedom from Major Amputation at 24 Months

At 24 months, Shockwave IVL supports limb preservation and sustained symptom improvement in high-risk patients with CLTI.

Rutherford Category Freedom from Major Amputation at 24 Months
Full Cohort (n=250) 94.8%1
RC 3 (n=50) 100%1
CLTI Cohort (n=200) 93.3%1
RC 4 (n=57) 98.1%2
RC 5 (n=143) 91.2%2

1: Chandra V, Two-Year Outcomes from the Disrupt PAD BTK II Study. VIVA. Las Vegas, NV; 2026.
2: Data on file at Shockwave Medical.

Rutherford Classification (RC) Change at 24 Months

24-month outcomes show continued durability of Shockwave IVL for calcified BTK treatment, demonstrating sustained clinical benefit in a complex CLTI population.

  • Of the patients remaining at 24 months, 82% were no longer CLTI1

1: Chandra V, Two-Year Outcomes from the Disrupt PAD BTK II Study. VIVA. Las Vegas, NV; 2026.

 

Quality of Life at 24 Months

Shockwave IVL facilitates sustained symptom improvement for patients with CLTI through 24 months.

Breakdown by Attribute VascuQoL-6 Attribute Activity Tired Walk Concern Social Pain
Average Score 24 Months1 3 2.8 3.1 3.1 3.3 2.9
Average Score Baseline2 1.9 2.0 2.3 1.7 2.3 1.8

 

Total VascuQoL-6 Score (CLTI) at 24 months significantly improved from baseline (P-Value: p<0.001). Total at 24 months was 18.1 ± 4.6 and total at baseline was 11.9 ± 4.0.1,2

The Vascular Quality of Life Questionnaire is a survey used to determine health related quality of life (HRQoL) in patients with peripheral arterial disease (PAD). Each attribute is scored 1-4, a higher value indicates better health status. The sum of each individual attribute score is used to generate a total quality of life score.

1: Data on file at Shockwave Medical.
2: Armstrong E, One-Year Outcomes from the Disrupt PAD BTK II Study. VIVA. Las Vegas, NV; 2025.

Study Leadership

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

  • Venita Chandra, MD
    Clinical Associate Professor of Surgery, Associate Program Director – Vascular Surgery, Medical Director Stanford Advanced Wound Center
  • Ehrin Armstrong, MD
    Medical Director, Aurora Denver Cardiology Associates, Swedish Medical Center
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