DISRUPT CAD II
European post-market study confirming DISRUPT CAD I results and showing strong safety and procedural success with Shockwave coronary Intravascular Lithotripsy (IVL).
Study Leadership
This section contains attributions including profile pictures, titles, descriptions, and Twitter handles.
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Prof. Jean FajadetCo-Principal Investigator Clinique Pasteur, Toulouse, France
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Prof. Carlo di MarioCo-Principal Investigator AOU Careggi SOD Interventistica Firenze, Italy
Statistics Callout
This section presents key statistical information with numbers and descriptions.
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120Patients
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15Hospitals
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94%Severe Ca++
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100%Successful delivery of Shockwave IVL
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100%Successful delivery of stents
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0%Severe dissections
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0%Perforations
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0%Slow/no reflow
Study Design and Patient Characteristics
Objective
A post-market study to assess the safety and performance of the coronary Shockwave IVL system with more patients in more centers
Primary Safety Endpoint
In-hospital major adverse cardiovascular event (MACE) (cardiac death, myocardial infarction or target vessel revascularization)
Secondary Performance Endpoint
Clinical and angiographic success
Patient Characteristics Summary
- 72 years old
- 32% diabetes mellitus (DM)
- 3.0 mm reference vessel diameter (RVD)
- 60% diameter stenosis
- 26 mm Ca++ length
- 72% concentric/28% eccentric lesions
- 30% side branch involvement
Stable angina, unstable angina or silent ischemia
Heavily calcified, de novo coronary lesions RVD 2.5 – 4.0 mm, stenosis ≥50%, lesion length ≤32 mm
Countries Included in Study
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Belgium
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Denmark
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France
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Germany
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Italy
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Netherlands
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Spain
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Sweden
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United Kingdom
Strong Performance and Safety with Low Complications
Accordion Section
| Performance Outcomes | Results |
| Clinical success | 94.2% (113) |
| Angiographic success | 100% (120) |
| Stent delivery | 100% (120) |
Clinical success: ability of Shockwave IVL to produce a residual diameter stenosis <50% after stenting with no evidence of in-hospital MACE.
| Final In-Stent Angiographic Outcomes (Core Lab) | Results |
| Residual diameter stenosis, % | 7.8% ± 7.1 |
| Acute gain, mm | 1.67 ± 0.49 |
| Residual diameter stenosis <50% | 100% (120) |
| Residual diameter stenosis <30% | 100% (120) |
| Safety Outcomes | Results |
| Final angiographic complications | 0.0% (0/120) |
| Dissections, type D-F | 0.0% (0/120) |
| Perforations | 0.0% (0/120) |
| Abrupt closure | 0.0% (0/120) |
| Slow flow | 0.0% (0/120) |
| No reflow | 0.0% (0/120) |
| Major adverse cardiac events in-hospital | 5.8% (7/120) |
| Cardiac death | 0.0% (0/120) |
| Non-Q-wave myocardial infarction | 5.8% (7/120) |
| Q-wave myocardial infarction | 0.0% (0/120) |
| Target vessel revascularization | 0.0% (0/120) |
| Major adverse cardiac events through 30 days* | 7.6% (9/119) |
| Cardiac death | 0.8% (1/119) |
| Non-Q-wave myocardial infarction | 5.9% (7/119) |
| Q-wave myocardial infarction | 0.8% (1/119) |
| Target vessel revascularization | 0.8% (1/119) |
| Stent thrombosis (definite or possible) | 1.7% (2/119) |
*10 MACE in 9 subjects
| DISRUPT CAD II OCT Sub-Study | Results |
| Calcium fracture, % | 78.7% (37/47) |
| Calcium fracture per lesion | 3.4% ± 2.6 |
OCT Case Example: Proximal Left Anterior Descending Artery (LAD) with Side Branch Involvement
- Severe Ca++: >270° and >1 mm thick
- Ca++ fractures: Multiple locations (white arrows)
- Final result: Full stent expansion large acute gain
More DISRUPT CAD Studies
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Single-arm, pre-market study demonstrating the safety and performance of Shockwave IVL in heavily calcified coronary lesions.Coronary IVL
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Largest and most rigorous Shockwave study showcasing the safety, effectiveness and ease of use of Shockwave coronary IVL .Coronary IVL
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Shockwave coronary study demonstrating the safety and effectiveness of Shockwave IVL within a Japanese patient population.Coronary IVL