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Disrupt CAD IV With the Shockwave Coronary IVL System
NA trial testing Lithotripsy in Coronary Artery Disease in 72 participants. Completed in 25 March 2022.
| Lead sponsor | Shockwave Medical, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 72 |
| Start date | 6 November 2019 |
| Primary completion | 8 May 2020 |
| Estimated completion | 25 March 2022 |
| Sites | 8 locations across Japan |
Shockwave Medical, Inc. — full company profile →
18 and older, 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 major adverse cardiac events (MACE) at 30 days - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR). The primary endpoints were analyzed using the Intent To Treat (ITT) population.
| Group | Value | 95% CI |
|---|---|---|
| Intent To Treat | 93.8 |
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
| Group | Value | 95% CI |
|---|---|---|
| Intent To Treat | 93.8 |
A secondary endpoint was 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 Intent To Treat Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Intent to Treat (ITT) | 63 |
A secondary endpoint was Angiographic Success defined as stent delivery with \<50%residual stenosis and without serious angiographic complications. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Intent to Treat (ITT) | 63 |
secondary endpoint was Procedural Success defined as stent delivery with aresidual stenosis \<=30% (core laboratory assessed) and without in-hospital MACE. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Intent to Treat (ITT) | 60 |
A secondary endpoint was Angiographic Success defined as stent delivery with\<=30% residual stenosis and without serious angiographic complications. These secondary endpoints were analyzed using the Intent To Treat Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Intent to Treat (ITT) | 63 |
A secondary endpoint was Serious Angiographic Complications defined as severedissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Intent to Treat (ITT) | 63 |
The MACE rate at 6 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)- is presented as Kaplan-Meier (K-M) estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Intent to Treat (ITT) | 7.8 |
The MACE rate at 12 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)- is presented as Kaplan-Meier (K-M) estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Intent to Treat (ITT) | 9.4 |
The MACE rate at 24 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)- is presented as Kaplan-Meier (K-M) estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Intent to Treat (ITT) | 12.6 |
Target Lesion Failure (TLF) is defined as cardiac death, target vessel MI (TV-MI) or ischemia-driven target lesion revascularization (ID-TLR), and is presented as proportions at 30 days. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Intent to Treat (ITT) | 6.3 |
Target Lesion Failure (TLF) is defined as cardiac death, target vessel MI (TV-MI) or ischemia-driven target lesion revascularization (ID-TLR). TLF is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.
| Group | Value | 95% CI |
|---|---|---|
| Intent to Treat (ITT) | 6.3 |
Time frame: within 30 days of index procedure for both Roll-In and Intent To Treat arms, and through 24 months for Intent To Treat 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-I… | Coronary IVL System(ITT) T… | Coronary IVL System(ITT) T… | Coronary IVL System (ITT) … |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | — | — | — | — |
| Coronary Artery Occlusion | Cardiac disorders | — | — | — | — |
| Peripheral arterial occlusive disease | Vascular disorders | — | — | — | — |
| Myocardial ischemia | Cardiac disorders | — | — | — | — |
| Angina Pectoris | Cardiac disorders | — | — | — | — |
| Arrhythmia | Cardiac disorders | — | — | — | — |
| Cardiac Failure Congestive | Cardiac disorders | — | — | — | — |
| Vertigo | Ear and labyrinth disorders | — | — | — | — |
| Cholecystitis | Hepatobiliary disorders | — | — | — | — |
| Haemorrhage | Vascular disorders | — | — | — | — |
| Myocardial Infarction | Cardiac disorders | — | — | — | — |
| Retroperitoneal Mass | Gastrointestinal disorders | — | — | — | — |
| Periodontitis | Infections and infestations | — | — | — | — |
| Angina unstable | Cardiac disorders | — | — | — | — |
| Large Intestine Polyp | Gastrointestinal disorders | — | — | — | — |
| Mechanical ileus | Gastrointestinal disorders | — | — | — | — |
| Oedema peripheral | General disorders | — | — | — | — |
| Bile duct stone | Hepatobiliary disorders | — | — | — | — |
| Jaundice | Hepatobiliary disorders | — | — | — | — |
| Cellulitis | Infections and infestations | — | — | — | — |
| Infected dermal cyst | Infections and infestations | — | — | — | — |
| Pelvic abscess | Infections and infestations | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Hyperkalaemia | Metabolism and nutrition disorders | — | — | — | — |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Reaction | System | Coronary IVL System(Roll-I… | Coronary IVL System(ITT) T… | Coronary IVL System(ITT) T… | Coronary IVL System (ITT) … |
|---|---|---|---|---|---|
| Coronary artery dissection | Cardiac disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Vascular Access Site Complication | Injury, poisoning and procedural complications | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — |
Most-reported serious reactions: Cerebrovascular accident, Coronary Artery Occlusion, Peripheral arterial occlusive disease, Myocardial ischemia, Angina Pectoris, Arrhythmia, Cardiac Failure Congestive, Vertigo.
Data from ClinicalTrials.gov NCT04151628 adverse events section.
The study design is a prospective, multicenter, single-arm 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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing