DISRUPT BTK II

Count on it: New data confirms Shockwave Intravascular Lithotripsy’s (IVL) impact below the knee (BTK): Acute, 30-day, 6-month, 12-month and 24-month outcomes in the global prospective, multi-center, single-arm IVL study assessing the safety and effectiveness of the Shockwave peripheral IVL system for the treatment of calcified, stenotic BTK lesions.

DISRUPT BTK II logo
DISRUPT BTK II logo

Full Cohort Key Findings

  • New Benchmark for CLTI

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

  • Confirmed Durability

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

  • Frontline BTK Strategy

    The DISRUPT BTK II 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.

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

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

Study cohort represents complex patients with challenging calcified lesions below the knee
Results validate Shockwave IVL as a safe and effective treatment for challenging calcific below-the-knee lesions with minimal need for provisional stenting

* 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. 

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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

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

Medical History

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  • 58.5
    %
    Patients had wounds at baseline
  • 15
    %
    Hemodialysis-dependent
  • 70
    %
    Diabetes mellitus

Rutherford Category 

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

Lesions 

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This section presents key statistical information with numbers and descriptions.

  • 85
    %
    Moderate-severe calcification†
  • 91 mm
    Mean calcified length
  • 30
    %
    Chronic total occlusions

*Enrollment of RC3 was capped at 20% | †PARC Definition
Armstrong E, One-Year Outcomes from the Disrupt PAD BTK II Study. VIVA. Las Vegas, NV; 2025.

IVL’s Safety Profile Confirmed in Challenging Calcium Below the Knee

IVL was confirmed to be a safe treatment option in a challenging patient and lesion cohort. 

STRONG SAFETY PROFILE

Post-IVL Final
N  268 lesions  290 lesions 
Any serious angiographic complication (total)  1.9% (5/268)  1.0% (3/290) 
Dissection (Type D-F)  0.7% (2/268)  0.3% (1/290) 
Total perforations 1.5% (4/268)  0.7% (2/290) 
Distal embolization1  0% (0/268)  0% (0/290) 
Slow flow/no reflow2  0% (0/268)  0% (0/290) 
Abrupt closure  0.4% (1/268)  0.3% (1/290) 
Thrombus   0% (0/268)  0% (0/290) 

 

Three patients with serious angiographic complications at final:  

  • One patient had one undiagnosed minor perforation (Grade I)  
  • One patient had a Grade II perforation seen pre-IVL balloon inflation, downgraded to Grade I after DES placement  
  • One patient experienced abrupt vessel closure despite DES placement for grade F dissection  

None of the three patients had adverse events through discharge. 

1: One patient had a distal thromboembolism post-IVL. Transluminal suction thrombectomy was performed and the event was successfully resolved although imaging was not provided to the core lab for assessment, therefore, data was not included in table.
2: No Reflow defined as reduced antegrade flow without evidence of residual stenosis or dissection at the treatment site.
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

IVL’s Effectiveness Confirmed in Challenging Calcium Below the Knee

IVL was confirmed to be effective at reducing lesion stenosis with minimal additional treatment therapy. 

Bar graph titled

Primary Effectiveness Endpoint

  • Final residual stenosis of ≤ 50% without serious angiographic complications: 97.9% (232/237, 95% CI 95.1%-99.3%)
  • Additional analysis: Final residual stenosis of ≤ 30% without serious angiographic complications: 74.1% (215/290, 95% CI 68.7%-79.1%)

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

Procedural Information

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This section presents key statistical information with numbers and descriptions.

  • 65
    %
    No pre-dilation
  • 65
    %
    No post-dilation
  • 4.9
    %
    Total stent/tack implant
  • 2.3
    %
    Provisional stent/tack implant*

*Remaining stent/tack implants were part of physicians’ standard algorithm.
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

Primary Safety Endpoint at 30-Days

Results for the primary safety endpoint at 30-days further confirm IVL’s safety and ongoing efficacy in challenging calcium below the knee. 

Measure   Rate  95% CI 
Major Adverse Limb Events (MALE) or Post-Operative Death (POD)  0.8% (2/242)  0.1% – 3.0% 
All-cause death  0.0% (0/242)  0.0% – 1.5% 
Above-ankle amputation of the index limb  0.8% (2/242)  0.1% – 3.0% 
Major reintervention  0.0% (0/242)  0.0% – 1.5% 

 

Two patients required above-ankle amputations of the index limb:  

  • One patient had worsening necrotizing fasciitis of the right foot and underwent amputation nine days after index procedure  
  • One patient had non healing wounds in multiple areas of the foot and had an amputation nine days after index procedure  

These events were reported as not related to the study device or procedure and the decision to amputate was made on clinical grounds by the treating physician.


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

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: Based on the internal cohort sub analysis.
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

24-month outcomes establish IVL’s role in limb salvage and enabling functional recovery.

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: Based on the internal cohort sub analysis.

 

Rutherford Classification 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.

  • RC 3 Cohort: 89% had ≥ 1 RC improvement
  • CLTI Cohort: 84% had ≥ 1 RC improvement

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

 

Quality of Life (QoL) at 24 Months

Shockwave IVL facilitates sustained symptom improvement through 24 months.

VascuQoL-6 Attribute Activity Tired Walk Concern Social Pain
Average Score
24 Months (RC 3)1		 3.1 2.8 3.2 3.1 3.5 3.1
Average Score
24 Months (CLTI)1		 3.0 2.8 3.1 3.1 3.3 2.9
Average Score
Baseline (RC 3)2		 1.9 2.0 2.3 2.1 2.6 1.9
Average Score
Baseline (CLTI)2		 1.9 2.0 2.3 1.7 2.3 1.8

 

  • All categories improved. Total VascuQoL-6 Score for both RC 3 and CLTI at 24 months significantly improved from baseline (P-Value: p<0.001).
  • RC 3: Total at 24 months was 18.8 ± 4.5 and total at baseline was 12.9 ± 3.8.
  • CLTI: Total at 24 months was 18.1 ± 4.6 and total at baseline was 11.9 ± 4.0.

1: Based on the internal cohort sub analysis.
2: Armstrong E, One-Year Outcomes from the Disrupt PAD BTK II Study. VIVA. Las Vegas, NV; 2025.
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.

Check out the DISRUPT BTK II 30-day Outcomes Publication to learn more

  • screenshot from video of doctor speaking

    DISRUPT BTK II Acute Outcomes: Physician Perspectives with Dr. Lakshminarayan & Prof. Holden

    Watch the Video
  • screenshot from video of doctor speaking

    DISRUPT BTK II Acute & 30-Day Outcomes with Dr. Venita Chandra and Dr. Ehrin Armstrong

    Watch the video
See All Clinical Evidence
See All Clinical Evidence
  • DISRUPT BTK
    Post-market, European study to assess the safety and performance of Shockwave IVL as a standalone therapy in heavily calcified infrapopliteal lesions out to 30 days.
    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

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.