Home / CLINICIANS / Clinical Evidence / CAD I
USA / International
cad 1 white

Impressive Results, Excellent Safety in CE Mark Study

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

DISRUPT CAD I

By The Numbers

60
Patients
100%
Moderate/Severe Calcified Lesions
7
European Sites
6
Month Follow-up
30
Day MACE = Primary Safety Endpoint
<50%
Residual Stenosis = Primary Performance Endpoint
Read the full DISRUPT CAD I study results in Circulation
Full Study Results

Countries Included in DISRUPT CAD I

World Map
Sweden

Dr. Matthias Götberg
Skane University Hospital
Scania, Sweden

United Kingdom

Dr. Carlo DiMario
Royal Brompton
London, England

 

Dr. Jonathan Hill
King’s College
London, England

Netherlands

Dr. Nicolas van Mieghem
Thorax Center, Erasmus MC
Rotterdam, Netherlands

France

Jean Fajadet
Clinic Pasteur
Toulouse, France

Australia

Dr. Ian Meredith
Monash Health
Melbourne, Australia

 

Dr. Robert Whitbourn
St Vincent’s
Melbourne, Australia

DISRUPT CAD I Study Flow

Inclusion:
Stable angina, unstable angina or silent ischemia
Moderate and severly calcified, de novo coronary lesions RVD 2.5 - 4.0 mm, stenosis ≥50%, lesion length ≤32mm

Strong Performance & Safety and Low Complications

Effectiveness
Results
Clinical Success‡†
Residual stenosis <50% post-PCI with no evidence of in-hospital MACE
95%
Device Success
Successful device delivery and IVL treatment at target lesion
98.3%
Stent Delivery
100%
Safety
Results
Events
30 day MACE‡ Cardiac death, MI or TVR
5%

Death N = 0

QWMI N = 0

*NQWMI N = 3

TVR N = 0

6 month MACE‡ Cardiac death, MI or TVR
8.5%

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%

DISRUPT CAD I OCT Sub-Study Confirms MOA of Intravascular Lithotripsy

31
Patients
3
OCT Runs: Baseline, Post-IVL & Post-Stent
43%
of lesions show calcium fractures
2.1mm2
acute area gain post-IVL
5.9mm2
minimal stent area
Full Sub-Analysis
Read the full DISRUPT CAD I OCT sub-analysis on the JACC: Cardiovascular Imaging website

OCT Sub-Analysis Key Findings

fracture img

Transmural Fractures

IVL Shown to Fracture Both Intimal and Medial Calcium Under OCT

fracture2

More Fractures

The More Severe the Calcium, the Greater the Incidence of Fracture

compliance

Improved Compliance

Improved Vessel Compliance Enables Similar Stent Expansion Across AllLesions, Despite Calcium Severity

A. Calcified, stenotic lesion
Treat with IVL
B. Large luminal gain with multiple calcium fractures (white arrows)
Deploy Stent
C. Stent expansion showing compliance and increased fracture size with additional increase in acute gain
chart1
chart2
chart3
A. Calcified, stenotic lesion
chart1
Treat with IVL
B. Large luminal gain with multiple calcium fractures (white arrows)
chart2
Deploy Stent
C. Stent expansion showing compliance and increased fracture size with additional increase in acute gain
chart3

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

Ready to Make Waves with Shockwave Medical?

Looking for careers? Click here.