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Count On It:
New Data Confirms IVL’s Impact Below the Knee (BTK)

Acute and 30-Day Outcomes

 

ENDPOINTS

 

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

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

Design

Prospective

Multi-center

Single-arm

Products included Shockwave M5+ and Shockwave S4

Key Inclusion

RC 3-5, RC 3 capped at 20% of enrolled patients

Moderate-severe calcification*

Up to two BTK lesions ≤ 200 mm in length

250
Patients
305
Lesions
38
Sites
2
Year follow-up

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

Complex Patients with Challenging Lesions Below the Knee

BTK II Complex Patients Graphic Updated

*Enrollment of RC3 was capped at 20% | †PARC Definition

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.

BTK II Safety Profile Graph Updated 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.

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.

BTK II Effective Calcium Modification Graph Revised BTK II Primary Effectiveness Endpoint

Procedural Information

65%
No pre-dilation
65%
No post-dilation
98%
Successful IVL catheter delivery across target lesion
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 for the primary safety endpoint at 30-days further confirms IVL's safety and ongoing efficacy in challenging calcium
below the knee.

BTK II Primary Safety Endpoint at 30 Days table 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.

BTK II Rutherford Category and QoL charts

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 Safety & Efficacy Confirmed for Challenging Calcific BTK Lesions

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

BTK II Clinical Insights Graphic

Chandra V, VIVA Late Breaking Clinical Trial 2024

 

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