CAD III

MAKING BIG WAVES
IN COMPLEX CALCIUM

LARGEST & MOST RIGOROUS SHOCKWAVE STUDY
Showcases Safety, Effectiveness & Ease of Use of Coronary IVL
JACC Publication
JACC
CAD III JACC PUBLICATION
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TCT Data Slides
TCT DATA SLIDES
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Key Findings

CAD III confirms IVL safety with low rates of major peri-procedural clinical and angiographic complications, setting a new bar for safety in complex coronary lesions.

  • 92.2% of patients were free from MACE at 30 days, a composite of CD (0.5%), MI (7.3%), or TVR (1.6%)
    • Primary MACE driver was in-hospital non-Q-wave MI (5.7%)
  • Low risk of perforation (0.3%), major dissection (0.3%), abrupt closure (0.3%), and slow flow/no reflow (0.0%) at the end of procedure

CAD III showcases IVL effectiveness with large lumen gains that facilitate stent delivery and optimize stent expansion.

  • 92.4% procedural success rate, defined as successful stent delivery (99%) residual stenosis <50% (100%), & without in-hospital MACE (93%)
  • Successful IVL crossing & therapy delivery in 98% of lesions, correlating to 99% stent delivery
  • 1.7mm acute gain and 11.9% final in-stent residual stenosis

CAD III demonstrated Coronary IVL’s ease of use and quick learning curve to achieve consistently predictable outcomes.

  • Despite >80% of operators having no prior experience with IVL, MACE, procedural success and device crossing success were similar between first roll-in first case and pivotal cohort
device

CAD III By The Numbers

DOWNLOAD CAD III HIGHLIGHTS
384
Patients at
47 Sites
100%
Severe Ca++
47.9mm
Calcium Length
98%
IVL Crossing & Therapy
Delivery
99%
Stent Delivery
0.3%
Final Major
Dissections
0.3%
Final Perforations
0.3%
Abrupt Closure
0%
Slow Flow/No Reflow
11.9%
Residual Stenosis
1.7mm
Acute Gain

DISRUPT CAD III Design & Patient Demographics

Stable angina, unstable angina or silent ischemia
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Heavily calcified, de novo coronary lesions RVD 2.5 – 4.0 mm, stenosis ≥50%, Lesion length ≤40 mm

Objective: Prospective, multicenter, single-arm global IDE to evaluate the safety and effectiveness of coronary IVL

Primary Safety Endpoint: Freedom from MACE at 30 days

  • Cardiac death, Myocardial infarction, or Target vessel revascularization

Primary Effectiveness Endpoint: Procedural success

  • Successful stent delivery with residual stenosis <50% and without in-hospital MACE

Secondary Performance Endpoints: Angiographic Success, Device Crossing Success, and Procedural Success with less than/equal to 30% RS threshold

Baseline Characteristics:

71 yo

40% DM

3.0mm RVD

65% DS

48mm Ca++ Length

26mm Lesion Length

57% LAD, 13% LCX, 29% RCA, 1% LM

292 Ca++Arc @ Max Ca++ Site

.96mm Thick Ca++ @ Max Ca++ Site

Large Circumferential Lumen Gains to Facilitate Stent Delivery, Apposition & Expansion

angriographic outcomes

Low Rates of Complications, Similar to DISRUPT CAD I & II

angriographic outcomes

Low Rates of MACE, Mostly Driven by In-Hospital NQWMI

angriographic outcomes

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