DISRUPT BTK II CLTI Cohort Analysis

Count on it: New data validates Shockwave Intravascular Lithotripsy’s (IVL) impact on patients with chronic limb threatening ischemia (CLTI) at 12 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

  • Wound Healing

    In a majority of patients with CLTI, IVL plays a critical role in laying the foundation for successful wound healing through safe and effective revascularization.

  • Limb Salvage

    12-month outcomes establish IVL’s role in limb salvage and enabling functional recovery in patients with CLTI.

  • Frontline Strategy

    The DISRUPT BTK II 12-month data establishes IVL as a frontline calcium modification* for complex BTK lesions, delivering outcomes that redefine the benchmark for success in the treatment of patients with CLTI.

Armstrong E, VIVA 2025
*The majority of patients enrolled had CLTI, thus a majority of the comorbidities are attributed to this population.

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

The DISRUPT BTK II study enrolled the largest cohort of real-world, complex patients* with moderate to severe calcium below the knee
DISRUPT BTK II sets a new benchmark for what’s possible for the challenging lesions. No other technology has been evaluated in such severely calcified BTK lesions to date

* 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. 

Statistics Callout

This section presents key statistical information with numbers and descriptions.

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

Full Cohort Baseline Demographics

Rutherford Category

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 57
    %
    RC 5, minor tissue loss
  • 23
    %
    RC 4, ischemic rest pain
  • 20
    %
    RC 3, severe claudication*

Medical History

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 59
    %
    Patients had wounds at baseline
  • 15
    %
    Hemodialysis-dependent
  • 70
    %
    Diabetes mellitus

Lesions

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 85
    %
    Moderate-severe Ca++†
  • 91
    mm
    Mean calcified length
  • 30
    %
    Chronic total occlusion (CTOs)

*Enrollment of RC 3 was capped at 20% | †PARC Definition

Chandra V, Lansky AJ, Sayfo S, et al. Thirty-Day Outcomes from the DISRUPT PAD BTK II Study of the Shockwave Intravascular Lithotripsy System for Treatment of Calcified Below-the-Knee Peripheral Arterial Disease. Journal of Vascular Surgery. Published online November 12, 2024. doi:10.1016/j.jvs.2024.11.003

The rest of this data is focused on the CLTI cohort

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, VIVA 2025
2: Data on File
*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, VIVA 2025
2: Data on File

Freedom from CD-TLR and Patency at 12 Months

12-month outcomes confirm the durability of IVL through sustained vessel patency and low reintervention rates which lead to limb preservation and ongoing symptom relief.

Rutherford Category Freedom from CD-TLR at 12 Months
Full Cohort (n=250) 84.5%1
RC 3 (n=50) 92.0%1
CLTI Cohort (n=200) 82.7%1
RC 4 (n=57) 88.0%2
RC 5 (n=143) 80.3%2
Patency at 12 Months (CLTI)
64.0% (n=80/125)1

1: Armstrong E, VIVA 2025
2: Data on File
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 12 Months

12-month outcomes establish IVL’s role in limb salvage and enabling functional recovery in patients with CLTI.

Rutherford Category Freedom from Major Amputation at 12 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: Armstrong E, VIVA 2025
2: Data on File

Rutherford Classification (RC) Change at 12 Months

IVL played a critical role in laying the foundation for successful wound healing in patients with CLTI through safe and effective revascularization.

  • Of the patients remaining at 12 months, 68% were no longer CLTI1
  • 61% of wounds were healed or improving1*

1: Data on File
Available data is 159 limbs out of 200 limbs of patients with CLTI.
*Mean wound follow up time: 157 days.

 

Quality of Life at 12 Months

As part of revascularization, IVL facilitates sustained symptom improvement for patients with CLTI through 12 months.

Breakdown by Attribute VascuQoL-6 Attribute Activity Tired Walk Concern Social Pain
Average Score 12 Months 2.8 2.6 3.0 2.9 3.1 2.8
Average Score Baseline 1.9 2.0 2.3 1.7 2.3 1.8

 

All categories improved. Total VascuQoL-6 Score (CLTI) at 12 months significantly improved from baseline (P-Value: p<0.001). Total at 12 months was 17.2 ± 5.0 and total at baseline was 11.9 ± 4.0.1

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: Armstrong E, VIVA 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