Coronary Artery Disease
Conditions
Brief summary
The objective of this post market study is to examine the safety and performance of the Shockwave Coronary Intravascular Lithotripsy System for the treatment of narrowed coronary arteries before the doctor places a stent.
Detailed description
The study will be conducted at 15 sites in Europe and up to 120 participants will be followed for 30 days post procedure. Patients ≥18 years of age scheduled for stent procedure with evidence of significant calcified stenosis of left main, or left anterior descending, right coronary artery or left circumflex will be eligible to enroll in the study. The primary endpoint of the study will evaluate major adverse cardiac events post procedure including 1) cardiac related death, 2) heart attack, and 3) intervention to treat the coronary artery that was previously treated at the procedure visit.
Interventions
DEVICEIVL Coronary Lithotripsy System
The coronary intravascular lithotripsy catheter is similar to other balloon devices that are routinely used during angioplasty procedures; however, it has electrodes inside the balloon which are designed to deliver energy to crack the calcified blockage using lithotripsy (acoustic energy).
Sponsors
Shockwave Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intravascular Coronary Lithotripsy System
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is ≥ 18 years of age 2. Troponin must be less than or equal to the upper limit of lab normal value within 24 hours prior to the procedure OR if troponin is elevated, concomitant CK must be normal 3. The target vessel must have a TIMI flow 3 at baseline 4. Patients with significant (≥ 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI 5. Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor) for 1 year and single antiplatelet therapy for life 6. Single lesion stenosis of protected LMCA, or LAD, RCA or LCX artery ≥50% in a reference vessel of 2.5 mm - 4.0 mm diameter and ≤ 32 mm length 7. Presence of calcification within the lesion on both sides of the vessel as assessed by angiography 8. Planned treatment of single lesion in one vessel 9. Ability to pass a 0.014 guide wire across the lesion 10. Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures 11. Patient is able and willing to comply with all assessments in the study
Exclusion criteria
1. Concomitant use of Atherectomy, Specialty balloon, or investigational coronary devices 2. Prior PCI procedure within the last 30 days of the index procedure 3. Patient has planned cardiovascular interventions within 30 days post index procedure 4. Second lesion with ≥50% stenosis in the same target vessel 5. Left ventricular ejection fraction \< 40% 6. Patient refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery 7. Uncontrolled severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg) 8. Severe renal failure with serum creatinine \>2.5 mg/dL, unless on chronic dialysis 9. Untreated pre-procedural hemoglobin \<10 g/dL 10. Coagulopathy manifested by platelet count \<100,000 or International Normalized ratio (INR) \>1.7 (INR is only required in patients who have taken warfarin within 2 weeks of enrollment) 11. Patients in cardiogenic shock 12. Acute myocardial infarction (MI) within the past one (1) month, and/or signs of active myocardial ischemia at the time of enrollment including elevated Troponin-I or T (with concomitant elevation of CK), ischemic ECG changes or chest pain 13. History of a stroke or transient ischemic attack (TIA) within 3 months 14. NYHA class III or IV heart failure 15. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months 16. Patients with a life expectancy of less than 1 year 17. Target vessel \< 2.4 mm in diameter 18. Target lesion \> 32 mm in length 19. Chronic Total Occlusion (CTO) 20. Previous stent procedure within 5 mm of target lesion 21. Angiographic evidence of a target lesion severe dissection prior to Coronary Lithoplasty treatment 22. Unprotected Left Main diameter stenosis ≥ 50% 23. Visible thrombus (by angiography) at target lesion site 24. Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass 25. Patient has active systemic infection 26. Patient has connective tissue disease (e.g., Marfan's syndrome) 27. Patient has a hypercoagulable disorder 28. Uncontrolled insulin dependent diabetes 29. Patient has allergy to imaging contrast media for which they cannot be pre-medicated 30. Evidence of aneurysm in target vessel 31. Patient is pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) | Post-procedure through hospital discharge | The primary endpoint is the frequency of in-hospital major adverse cardiac events (MACE). MACE is defined as the following: * Cardiac death * Myocardial Infarction - defined as a CK-MB level \> 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave * TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Success | During procedure through hospital discharge | Performance will be assessed by the ability of the Lithotripsy System to produce acceptable residual stenosis (\<50%) after stenting with no evidence of in-hospital MACE. Each patient that achieves both of these requirements will be considered a clinical success, and the rate of clinical success among subjects will be evaluated. |
| Number of Participants With Angiographic Success | During procedure | Angiographic success defined as success in facilitating stent delivery with \<50% residual stenosis and without serious angiographic complications. Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow. |
| Number of Participants Which Experienced Cardiac Death | 30 days post-procedure | Number of patients who experienced a cardiac death at 30 days post-procedure. |
Countries
Belgium, Denmark, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Participant flow
Recruitment details
Study recruitment and enrollment took place at 15 clinical sites in 9 European countries between May 2018 and March 2019. A total of 120 subjects with calcified, stenotic de novo coronary arteries were enrolled and treated with the Coronary Intravascular Lithotripsy (IVL) System.
Participants by arm
| Arm | Count |
|---|---|
| Coronary Intravascular Lithotripsy (IVL) System All enrolled patients will receive treatment from the coronary intravascular lithotripsy (IVL) system prior to coronary stent placement.
Coronary Intravascular Lithotripsy (IVL) System: The coronary intravascular lithotripsy catheter is similar to other balloon devices that are routinely used during angioplasty procedures; however, it has electrodes inside the balloon which are designed to deliver energy to crack the calcified blockage using lithotripsy (acoustic energy). | 120 |
| Total | 120 |
Baseline characteristics
| Characteristic | Coronary Intravascular Lithotripsy (IVL) System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 89 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants |
| Race (NIH/OMB) White | 94 Participants |
| Region of Enrollment Belgium | 9 participants |
| Region of Enrollment Denmark | 1 participants |
| Region of Enrollment France | 19 participants |
| Region of Enrollment Germany | 29 participants |
| Region of Enrollment Italy | 25 participants |
| Region of Enrollment Netherlands | 4 participants |
| Region of Enrollment Spain | 13 participants |
| Region of Enrollment Sweden | 1 participants |
| Region of Enrollment United Kingdom | 19 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 120 |
| other Total, other adverse events | 29 / 120 |
| serious Total, serious adverse events | 13 / 120 |
Outcome results
Primary
Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
The primary endpoint is the frequency of in-hospital major adverse cardiac events (MACE). MACE is defined as the following: * Cardiac death * Myocardial Infarction - defined as a CK-MB level \> 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave * TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
Time frame: Post-procedure through hospital discharge
Population: No imputation of or adjustments for missing data were performed for the primary analysis. The population for all analysis was the Intent-To-Treat (ITT) analysis set. ITT was defined as those subjects who had insertion of the IVL catheter attempted, defined as the point of enrollment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coronary Intravascular Lithotripsy (IVL) System | Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) | 7 Participants |
Secondary
Number of Participants Which Experienced Cardiac Death
Number of patients who experienced a cardiac death at 30 days post-procedure.
Time frame: 30 days post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coronary Intravascular Lithotripsy (IVL) System | Number of Participants Which Experienced Cardiac Death | 1 Participants |
Secondary
Number of Participants With Angiographic Success
Angiographic success defined as success in facilitating stent delivery with \<50% residual stenosis and without serious angiographic complications. Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
Time frame: During procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coronary Intravascular Lithotripsy (IVL) System | Number of Participants With Angiographic Success | 120 Participants |
Secondary
Number of Participants With Clinical Success
Performance will be assessed by the ability of the Lithotripsy System to produce acceptable residual stenosis (\<50%) after stenting with no evidence of in-hospital MACE. Each patient that achieves both of these requirements will be considered a clinical success, and the rate of clinical success among subjects will be evaluated.
Time frame: During procedure through hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coronary Intravascular Lithotripsy (IVL) System | Number of Participants With Clinical Success | 120 Participants |