DISRUPT CAD I CE Mark Study

A single-arm, pre-market study demonstrating the safety and performance of Shockwave Intravascular Lithotripsy (IVL) in heavily calcified, coronary lesions prior to stenting and followed to 6 months; also included an OCT sub-study demonstrating Shockwave IVL’s mechanism of action.

Study Leadership

Jean Fajadet, MD

Clinical Pasteur, Toulouse, France
Prof. Carlo Di Mario

AOU Careggi SOD Interventistica, Firenze, Italy

60

Patients
7

European sites
100

%

Severe calcified lesions
6

Month follow-up

Study Design and Patient Characteristics

Objective

A single-arm, pre-market study demonstrating the safety and performance of Shockwave IVL in heavily calcified, coronary lesions prior to stenting and followed to 6 months; also included an OCT sub-study demonstrating Shockwave IVL’s mechanism of action.

Primary Safety Endpoint

30-day major adverse cardiovascular event (MACE)

Secondary Performance Endpoint

<50% residual stenosis post-percutaneous coronary intervention (PCI) with no evidence of in-hospital MACE

Patient Characteristics Summary

Stable angina, unstable angina or silent ischemia
Moderate and severely calcified, de novo coronary lesions right ventricular systolic dysfunction (RVD) 2.5 – 4.0 mm, stenosis ≥50%, lesion length ≤32 mm

100% severe calcified lesions 

95% clinical success; 98.3% device success & Shockwave IVL treatment at target lesion; 100% stent delivery

Countries Included in Study

Australia
France
Netherlands
Sweden
United Kingdom

Strong Safety and Low Complications

Safety	Results	Events
30-day MACE* cardiac death, myocardial infarction (MI) or tricuspid valve replacement (TVR)	5%	Cardiac death N = 0 QWMI N = 0 **NQWMI N = 3 TVR N = 0
6-month MACE* cardiac death, myocardial infarction (MI) or tricuspid valve replacement (TVR)	8.3%	Cardiac death N = 2 QWMI N = 0 **NQWMI N = 3 TVR N = 0

Core lab adjudicated
*CEC adjudicated
**NQMI defined as 3x upper limit CK-MB

Complications	Procedural	Final
Dissection (D / E / F)	3.3% / 0% / 0%	0% / 0% / 0%
Perforation	0.0%	0.0%
Abrupt closure	0.0%	0.0%
Slow flow	0.0%	0.0%
No reflow	0.0%	0.0%

Brinton et al 2019 in Circ Int.

DISRUPT CAD I OCT Sub-Study Confirms Mechanism of Action (MOA) of Shockwave Intravascular Lithotripsy

31

Patients
3

OCT runs: Baseline, post-IVL & post-stent
55%

Fracture post-stent
2.1 mm

²

Acute area gain post-IVL
5.9 mm

²

Minimal stent area

Read the full DISRUPT CAD I OCT sub-analysis on the JACC: Cardiovascular Imaging website:

Read the Analysis

OCT Sub-Analysis Key Findings

Transmural fractures: Shockwave IVL shown to fracture both intimal and medial calcium under OCT
More fractures: The more severe the calcium, the greater the incidence of fracture
Improved compliance: Improved vessel compliance enables similar stent expansion across all lesions, despite calcium severity

Frames are co-registered to ensure cross-sections are in the same location.

More DISRUPT CAD Studies

See All Clinical Evidence

DISRUPT CAD II

European post-market study confirming DISRUPT CAD I results and showing strong safety and procedural success with Shockwave coronary IVL.

Coronary IVL
DISRUPT CAD III

Largest and most rigorous Shockwave study showcasing safety, effectiveness and ease of use of Shockwave coronary IVL. 

Coronary IVL
DISRUPT CAD IV

Shockwave coronary study demonstrating the safety and effectiveness of Shockwave IVL within a Japanese patient population.

Coronary IVL