Coronary Artery Disease, Myocardial Infarction
Conditions
Keywords
Intravasular Lithotripsy, PCI
Brief summary
This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo, calcified, stenotic, coronary lesions prior to stenting.
Detailed description
The Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting. Up to 145 subjects (138 evaluable) subjects with de novo, calcified coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI) will be enrolled at up to 20 US sites. Enrollment duration will be approximately 10-12 months and study duration will be approximately 2 years. Each subject will be followed through discharge, 30 days, 6, and 12 months.
Interventions
DEVICEIVL with Shockwave C2+ 2Hz Coronary IVL Catheter
Lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.
Sponsors
Shockwave Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Shockwave C2+ 2Hz Coronary IVL Catheter with Shockwave Intravascular Lithotripsy (IVL) System
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects are required to meet all of the following inclusion criteria in order to be enrolled in the clinical study. General Inclusion Criteria 1. Subject is ≥18 years of age 2. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI 3. For subjects with unstable ischemic heart disease, biomarkers (CK-MB and troponin) must be less than or equal to the upper limit of the laboratory normal within 12 hours prior to the procedure (note: both must be normal) 4. For subjects with stable ischemic heart disease, biomarkers may be drawn prior to the procedure or at the time of the procedure from the side port of the sheath 1. If drawn prior to the procedure, biomarkers (CK-MB and troponin) must be less than or equal to the upper limit of the laboratory normal within 12 hours of the procedure (note: both must be normal) 2. If drawn at the time of the procedure from the side port of the sheath prior to any intervention, biomarker results do not need to be analyzed prior to enrollment 5. Left ventricular ejection fraction \>25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criterion; may be assessed at time of index procedure) 6. Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures 7. Non-target lesions requiring PCI may be treated either 1. \>30 days prior to the study procedure if the procedure was unsuccessful or complicated; or 2. \>24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis \<30% and TIMI 3 flow (visually assessed) for all non-target lesions and vessels without perforation, cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, and with no post-procedure biomarker elevation \>normal; or 3. \>30 days after the study procedure Angiographic Inclusion Criteria 8. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure 9. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with 1. Stenosis of ≥70% and \<100%, or 2. Stenosis ≥50% and \<70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR \<0.90 or IVUS or OCT minimum lumen area ≤4.0 mm2 10. The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm 11. The lesion length must not exceed 40 mm 12. The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre- dilatation) 13. Evidence of calcification at the lesion site by, a) angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, OR by b) IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section 14. Ability to pass a 0.014" guide wire across the lesion
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure | within 30 days of index procedure | Freedom from MACE within 30 days of the index procedure. MACE is defined as a composite occurrence of: cardiac death, myocardial infarction (MI), target vessel revascularization (TVR) after the completion of the index procedure. |
| Percentage of Participants With Procedural Success (Residual Stenosis ≤30%) | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure | Procedural Success post stent delivery with a residual stenosis ≤30% (core laboratory assessed) and without in-hospital MACE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Device Crossing Success | at the end of procedure | Device Crossing Success is defined as the ability to deliver the IVL catheter across the target lesion, and delivery of lithotripsy without serious angiographic complications immediately after IVL. |
| Number of Participants With Angiographic Success (Residual Stenosis <50%) | at the end of procedure | Angiographic Success defined as stent delivery with \<50% residual stenosis and without serious angiographic complications. |
| Number of Participants With Procedural Success (Residual Stenosis <50% and Without In-hospital MACE) | at the end of the procedure | Procedural Success defined as stent delivery with a residual stenosis \<50% (core laboratory assessed) and without in-hospital MACE. |
| Number of Participants With Angiographic Success (Residual Stenosis ≤30%) | at end of procedure | Angiographic Success defined as stent delivery with ≤30% residual stenosis and without serious angiographic complications. |
| Number of Participants With Serious Angiographic Complications | at end of procedure | Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow. |
| Target Lesion Failure Rate at 30 Days | within 30 days of index procedure | 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. |
| All-Cause Death Rate at 30 Days | within 30 days of index procedure | Percentage of participants who experienced death (all-cause) through 30 days post index procedure. |
| Cardiac Death Rate at 30 Days | within 30 days of index procedure | Percentage of participants who experienced cardiac death through 30 days post index procedure |
| MI Rate at 30 Days | within 30 days of index procedure | Percentage of participants who experienced myocardial infarction through 30 days post index procedure |
| Target Vessel-MI (TV-MI) Rate at 30 Days | within 30 days of index procedure | Percentage of participants who experienced MI attributable to the target vessel through 30 days post index procedure |
| Procedural MI Rate at 30 Days | within 30 days of index procedure | Percentage of participants who experienced procedural myocardial infarction through 30 days post index procedure |
| Non-Procedural MI Rate at 30 Days | within 30 days of index procedure | Percentage of participants who experienced Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition) through 30 days post index procedure |
| Ischemia Driven-Target Vessel Revascularization (ID-TVR) Rate at 30 Days | within 30 days of index procedure | Percentage of participants who experienced a Ischemia-Driven Target Vessel Revascularization through 30-days post index procedure |
| Ischemia-Driven Target Lesion Revascularization (ID-TLR) Rate at 30 Days | within 30 days of index procedure | Percentage of participants who experienced a Ischemia-Driven Target Lesion Revascularization through 30-days post index procedure |
| Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) Rate at 30 Days | within 30 days of index procedure | Percentage of participants who experienced a Non-Ischemia-Driven Target Vessel Revascularization through 30-days post index procedure |
| Non-ID-TLR Rate at 30 Days | within 30 days of index procedure | Percentage of participants who experienced a Non-Ischemia-Driven Target Lesion Revascularization through 30-days post index procedure |
| Any Revascularizations Rate at 30 Days | within 30 days of index procedure | Percentage of participants who experienced any revascularizations (ID and non-ID) through 30 days post index procedure. |
| Stent Thrombosis Rate at 30 Days | within 30 days of index procedure | Percentage of participants who experienced any stent thrombosis (definite, probable, definite or probable) through 30 days post index procedure. |
| Rate of MI Using the 4th Universal Definition at 30 Days | within 30 days of index procedure | Percentage of participants who experienced MI using the 4th Universal Definition through 30 days post index procedure. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Mean | 70.5 years STANDARD_DEVIATION 9 |
| BMI Categories 1 Healthy weight | 33 Participants |
| BMI Categories 1 Obesity | 56 Participants |
| BMI Categories 1 Overweight | 55 Participants |
| BMI Categories 1 Underweight | 1 Participants |
| Body Mass Index | 29.3 kg/m^2 STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 134 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 9 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 5 Participants |
| Race/Ethnicity, Customized Unknown/ Not specified | 1 Participants |
| Race/Ethnicity, Customized White | 120 Participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 145 |
| other Total, other adverse events | 9 / 145 |
| serious Total, serious adverse events | 13 / 145 |
Outcome results
None listed