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Disrupt CAD III With the Shockwave Coronary IVL System
NA trial testing Lithotripsy in Coronary Artery Disease in 431 participants. Completed in 10 April 2022.
| Lead sponsor | Shockwave Medical, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 431 |
| Start date | 9 January 2019 |
| Primary completion | 7 May 2020 |
| Estimated completion | 10 April 2022 |
| Sites | 48 locations across France, United Kingdom, United States, Germany |
Shockwave Medical, Inc. — full company profile →
Eligibility, any sex, with Coronary Artery Disease or Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary safety endpoint was freedom from MACE at 30 days - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR). The primary endpoints were analyzed using the Pivotal Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Coronary IVL System (Pivotal) | 92.2 | 89.9 – NA |
The primary effectiveness endpoint was Procedural Success defined as stent delivery with a residual in-stent stenosis \<50% (core laboratory assessed) and without in-hospital MACE. The primary endpoints were analyzed using the Pivotal Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Coronary IVL System (Pivotal) | 92.4 | 90.2 – NA |
Device Crossing Success defined as the ability to deliver the IVL catheter across the target lesion, and delivery of lithotripsy without serious angiographic complications immediately after IVL. The secondary endpoints were analyzed using the Pivotal Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Coronary IVL System (Pivotal) | 368 |
Angiographic Success defined as stent delivery with \<50% residual stenosis and without serious angiographic complications. The secondary endpoints were analyzed using the Pivotal Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Coronary IVL System (Pivotal) | 370 |
Procedural Success defined as stent delivery with a residual stenosis \<=30% (core laboratory assessed) and without in-hospital MACE. The secondary endpoints were analyzed using the Pivotal Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Coronary IVL System (Pivotal) | 354 |
Angiographic Success defined as stent delivery with \<=30% residual stenosis and without serious angiographic complications. The secondary endpoints were analyzed using the Pivotal Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Coronary IVL System (Pivotal) | 369 |
Serious Angiographic Complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow. The secondary endpoints were analyzed using the Pivotal Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Coronary IVL System (Pivotal) | 12 |
MACE at 6 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Coronary IVL System (Pivotal) | 10.2 |
MACE at 12 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Coronary IVL System (Pivotal) | 13.6 |
MACE at 24 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Coronary IVL System (Pivotal) | 18.9 |
Target lesion failure (TLF) is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. 30 day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Coronary IVL System (Pivotal) | 7.6 |
TLF is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Coronary IVL System (Pivotal) | 9.1 |
Time frame: within 30 days of index procedure for both Roll-In and Pivotal arms, and through 24 months for Pivotal arm only. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Coronary IVL System (Roll-… | Coronary IVL System (Pivot… | Coronary IVL System (Pivot… | Coronary IVL System (Pivot… |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | — | — | — | — |
| Infection | Infections and infestations | — | — | — | — |
| Arrhythmia | Cardiac disorders | — | — | — | — |
| Angina pectoris | Cardiac disorders | — | — | — | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Coronary artery dissection | Cardiac disorders | — | — | — | — |
| Sepsis | Infections and infestations | — | — | — | — |
| Non-cardiac chest pain | General disorders | — | — | — | — |
| Coronary artery restenosis | Injury, poisoning and procedural complications | — | — | — | — |
| Renal failure | Renal and urinary disorders | — | — | — | — |
| Aortic stenosis | Vascular disorders | — | — | — | — |
| Cardiac arrest | Cardiac disorders | — | — | — | — |
| Cardiac failure congestive | Cardiac disorders | — | — | — | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — | — | — | — |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Cerebrovascular accident | Nervous system disorders | — | — | — | — |
| Cardiac failure acute | Cardiac disorders | — | — | — | — |
| Presyncope | Nervous system disorders | — | — | — | — |
| Syncope | Nervous system disorders | — | — | — | — |
| Haemorrhage | Vascular disorders | — | — | — | — |
| Coronary artery occlusion | Cardiac disorders | — | — | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Reaction | System | Coronary IVL System (Roll-… | Coronary IVL System (Pivot… | Coronary IVL System (Pivot… | Coronary IVL System (Pivot… |
|---|---|---|---|---|---|
| Myocardial necrosis marker increased (elevated cardiac biomarker) | Investigations | — | — | — | — |
| Angina pectoris | Cardiac disorders | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Infection | Infections and infestations | — | — | — | — |
| Arrhythmia | Cardiac disorders | — | — | — | — |
| Non-cardiac chest pain | General disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Coronary artery dissection | Cardiac disorders | — | — | — | — |
Most-reported serious reactions: Myocardial infarction, Infection, Arrhythmia, Angina pectoris, Respiratory failure, Coronary artery dissection, Sepsis, Non-cardiac chest pain.
Data from ClinicalTrials.gov NCT03595176 adverse events section.
The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting. Disrupt CAD III is being conducted as a staged pivotal study.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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