DISRUPT BTK II

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

DISRUPT BTK II logo
DISRUPT BTK II logo

Study Leadership

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  • Venita Chandra, MD
    Clinical Associate Professor of Surgery, Associate Program Director – Vascular Surgery, Medical Director Stanford Advanced Wound Center
  • Ehrin Armstrong, MD
    Medical Director Adventist Heart and Vascular Institute

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 further validate Shockwave IVL as a very safe and effective treatment for challenging calcific below-the-knee lesions with low complications & a 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. 

Statistics Callout

This section presents key statistical information with numbers and descriptions.

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

Complex Patients with Challenging Lesions Below the Knee  

Medical History 

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 46
    %
    Patients had wounds at baseline
  • 15
    %
    Hemodialysis-dependent
  • 70
    %
    Diabetes mellitus

Rutherford Category 

Statistics Callout

This section presents key statistical information with numbers and descriptions.

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

Lesions 

Statistics Callout

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

IVL’s Safety Profile Confirmed in More Challenging Calcium in BTK II Patients

IVL demonstrated low levels of serious complications in the complex BTK II patient cohort.

Strong Safety Profile

Angiographic Complications (Core Lab)

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.
*There were 305 core lab reported lesions at pre-procedure; 268 lesions had available and assessable images post-IVL; 290 lesions had available and assessable images at final.

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 chart illustrating the reduction in diameter stenosis across three stages: Pre-procedure at 78%, Post-Intravascular Lithotripsy (IVL) at 29%, and Final at 26%.

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%)

Procedural Information

Statistics Callout

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.

Primary Safety Endpoint at 30-Days

Results further confirm IVL’s safety profile in the challenging calcium enrolled in BTK II, following the BTK I study.

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% (2/242)  0.0% – 1.5% 
Above-ankle amputation of the index limb  0.8% (2/242)  0.1% – 3.0% 
Major reintervention  0.0% (2/242)  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. 

Rutherford Category (RC) & Quality of Life (QoL) at 30-Days

Significant positive shift in RC and QoL at 30-days. 

Two sections showing significant improvement in health metrics after a 30-day period. The left section features two bar charts indicating improvements in Rutherford Category (RC) for target limbs. The baseline chart shows 0% in categories 0-2, with higher percentages in categories 3-5, peaking at 57% in RC 5. After 30 days, the percentages shift, with 30% in RC 0, and a peak of 45% in RC 5. The right section shows an improvement in the VascuQoL score from a baseline of 12.1 to 16.1 at 30 days, with a p-value <0.001, indicating statistical significance.

 

*Nordanstig, Joakim et al. Journal of Vascular Surgery, Volume 59, Issue 3, 700 -707.e1
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. 

IVL’s Strong Safety & Efficacy Data Confirmed for Challenging Calcific BTK Lesions 

30-day results further validate IVL as a very safe and effective treatment for challenging calcific BTK lesions with low complications and a minimal need for provisional stenting.

Strong Safety Confirmed Effectiveness Minimal Provisional Stenting
Total serious angiographic complications:

1.9% post-IVL

1.0% at final

 Average residual stenosis: 

29% post-IVL

26% at final

 Stent/tack implant:

Total/stent tack implant: 4.9%

Provisional stent/tack implant: 2.3%*

 

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

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

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
    Global prospective, multi-center, single-arm study assessing the safety and effectiveness of Shockwave peripheral IVL in treating long, calcified BTK lesions.
    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.