PRIMARY

EFFECTIVENESS ENDPOINT:

Procedure success defined as ≤50% residual stenosis for all treated lesions without significant angiographic complications

DISRUPT BTK II

By The Numbers

250
Patients
40
Global sites
Lesion lengths up to 200mm
Outcomes out to 2 Years

DISRUPT BTK II
STUDY LEADERSHIP

Venita Chandra MD
Clinical Associate Professor of Surgery
Associate Program Director - Vascular Surgery
Medical Director - Stanford Advanced Wound Center
IVL in Complex CLI Cases with Ehrin Armstrong MD
Medical Director – Adventist Heart and Vascular Institute
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Dr. Armstrong CLI Case: Nonhealing Wound to Right Great Toe & Non-compressible ABI
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Dr. Armstrong CLI Case: Complex Intervention – Nonhealing Left 2nd, 3rd, & 4th Digits
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Dr. Armstrong CLI Case: Inframalleolar Disease with Occlusion of Plantar Artery
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Dr. Armstrong CLI Case: PMH of Diabetes & CKD – Nonhealing Wound of Plantar Surface of 4th Digit

DISRUPT BTK II
TRIAL DESIGN SIGNIFICANCE

Studies a real-world CLI patient population, including patients with long, calcified lesions.

Prospective, multi-center, core lab adjudicated.

Moderate-severe calcium assessed by angiography or IVUS.

IVL is the definitive treatment.

Secondary Endpoints: Primary Patency, Clinically Relevant TLF, ABI/TBI & RC, QoL, Wound Healing.

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