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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.
Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention. Approximately 72 subjects at 8 sites in Japan will be enrolled. Subjects will be followed through discharge, 30 days, 6, 12 and 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary Lithotripsy System | Experimental | All subjects will receive lithotripsy treatment from the Shockwave Medical Coronary IVL System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithotripsy | Device | Deliver Lithotripsy to the target vessel prior to placing a coronary stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced Freedom From MACE Within 30 Days Post-procedure | 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. | Within 30 days of index procedure |
| Percentage of Subjects With Procedural Success | 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 | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Device Crossing Success | 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. | At end of procedure, with a mean total procedure time of 62.5 minutes |
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Inclusion Criteria:
Subject is ≥18 years of age
Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
For patients with unstable ischemic heart disease, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours prior to the procedure (note: if both labs are drawn both must be normal)
For patients 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.
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 criteria; may be assessed at time of index procedure)
Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
Lesions in non-target vessels requiring PCI may be treated either:
>30 days prior to the study procedure if the procedure was unsuccessful or complicated; or
>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
>30 days after the study procedure
Angiographic Inclusion Criteria
The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with:
The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm
The lesion length must not exceed 40 mm
The target vessel must have TIMI flow 3 at baseline (visually assessed, may be assessed after pre-dilatation)
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
Ability to pass a 0.014" guide wire across the lesion
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregg W Stone, MD | Columbia University | Study Chair |
| Shigeru Saito, MD | Shonan Kamakura General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tenjinkai Shin-Koga Hospital | Kurume | Fukuoka | 830-8577 | Japan | ||
| Sapporo Higashi Tokushukai Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33551398 | Result | Saito S, Yamazaki S, Takahashi A, Namiki A, Kawasaki T, Otsuji S, Nakamura S, Shibata Y; Disrupt CAD IV Investigators. Intravascular Lithotripsy for Vessel Preparation in Severely Calcified Coronary Arteries Prior to Stent Placement - Primary Outcomes From the Japanese Disrupt CAD IV Study. Circ J. 2021 May 25;85(6):826-833. doi: 10.1253/circj.CJ-20-1174. Epub 2021 Feb 5. | |
| 33939604 |
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72 subjects were consented and enrolled into the study
Study enrollment took place at 8 study centers in Japan between November 6, 2019 and April 6, 2020. A total of 72 subjects with de novo, calcified, stenotic coronary arteries were enrolled and treated with the Coronary Intravascular Lithotripsy (IVL) System
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| ID | Title | Description |
|---|---|---|
| FG000 | Roll-in | The first subject enrolled at each site is considered a roll-in. Data on roll-in subjects were collected through 30 days, at which time subject participation was complete. |
| FG001 | Intent to Treat (ITT) | The Intent to Treat (ITT) population was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on the ITT population was collected through 30 days for primary endpoints. Long-term follow-up for the ITT population to 24 months is complete. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Roll-in | The first subject enrolled at each site is considered a roll-in. Data on roll-in subjects were collected through 30 days, at which time subject participation was complete. |
| BG001 | Intent to Treat (ITT) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Experienced Freedom From MACE Within 30 Days Post-procedure | 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. | ITT population was the primary analysis cohort; data on roll-in subjects was only collected through 30 days. Data collected from the roll-in subjects were not pre-specified to be reported as a Primary or Secondary Outcome Measure; therefore, only the ITT arm is reported. The ITT population includes all subjects enrolled in the pivotal phase of the study. This population does not include roll-in subjects. | Posted | Number | percentage of participants | Within 30 days of index procedure |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Coronary IVL System(Roll-In) Through 30Days | Adverse events reported through 30 days post-procedure for Roll-In subjects. The first subject enrolled at each site is considered a roll-in. Per protocol, data on roll-in subjects were collected through 30days, at which time subject participation was complete. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Occlusion | Cardiac disorders | MedDRA version 21.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery dissection | Cardiac disorders | MedDRA version 21.1 | Systematic Assessment | Roll-In group does not meet 5% frequency threshold for reporting |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randee Randoll, Director Clinical Affairs | Shockwave Medical Inc | 1-408-577-7856 | rrandoll@shockwavemedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2019 | Apr 22, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008096 | Lithotripsy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D059708 | Ultrasonic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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The Coronary IVL System is a proprietary balloon catheter system designed to enhance stent outcomes by enabling delivering of the calcium disrupting capability of lithotripsy prior to balloon dilatation at low pressures. The Coronary IVL System consists of an IVL Balloon Catheter with 2 integrated emitters, a Lithotripsy Generator, and a Connector Cable.
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| Number of Participants With Angiographic Success (Residual Stenosis <50%) | 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. | At end of procedure, with a mean total procedure time of 62.5 minutes |
| Number of Participants With Procedural Success (Residual Stenosis <=30%) | 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. | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure |
| Number of Participants With Angiographic Success (Residual Stenosis <=30%) | 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. | At end of procedure, with a mean total procedure time of 62.5 minutes |
| Number of Participants With Serious Angiographic Complications | 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. | At end of procedure, with a mean total procedure time of 62.5 minutes |
| MACE Rate at 6 Months | 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. | within 6 months of index procedure |
| MACE Rate at 12 Months | 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. | within 12 months of index procedure |
| MACE Rate at 24 Months | 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. | within 24 months of index procedure |
| Target Lesion Failure (TLF) at 30 Days | 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. | Within 30 days of index procedure |
| Target Lesion Failure (TLF) at 6 Months | 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. | Within 6 months of index procedure |
| Target Lesion Failure (TLF) at 12 Months | 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 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Within 12 months of index procedure |
| Target Lesion Failure (TLF) at 24 Months | 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 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Within 24 months of index procedure |
| All-Cause Death at 30 Days | The 30-day rates of all-cause death are presented as proportions. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Within 30 days from index procedure |
| All-Cause Death at 6 Months | All-cause death at 6 months is presented as Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 6 months of index procedure |
| All-Cause Death at 12 Months | All-cause death at 12 month is presented as Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 12 months of procedure |
| All-Cause Death at 24 Months | All-cause death at 24 month is presented as Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 24 months of procedure |
| Myocardial Infarction (MI) at 30 Days | The 30-day MI rates are presented as proportions. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 30 days of index procedure |
| Myocardial Infarction (MI) at 6 Months | MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Within 6 months of index procedure |
| Myocardial Infarction (MI) at 12 Months | MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Within 12 months of index procedure |
| Myocardial Infarction (MI) at 24 Months | MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Within 24 months of index procedure |
| Myocardial Infarction Attributable to Target Vessel (TV-MI) at 30 Days | The Myocardial Infarction attributable to the target vessel (TV-MI) rates at 30 days are presented as proportions. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 30 days of index procedure |
| Myocardial Infarction Attributable to Target Vessel (TV-MI) at 6 Months | The Myocardial Infarction attributable to the target vessel (TV-MI) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Within 6 month of index procedure |
| Myocardial Infarction Attributable to Target Vessel (TV-MI) at 12 Months | The Myocardial Infarction attributable to the target vessel (TV-MI) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Within 12 months of index procedure |
| Myocardial Infarction Attributable to Target Vessel (TV-MI) at 24 Months | The Myocardial Infarction attributable to the target vessel (TV-MI) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Within 24 months of index procedure |
| Stent Thrombosis at 30 Days | The Stent Thrombosis rate at 30 days is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Within 30 days of index procedure |
| Stent Thrombosis at 6 Months | Stent thrombosis is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 6 months of index procedure |
| Stent Thrombosis at 12 Months | Stent thrombosis is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 12 months of index procedure |
| Stent Thrombosis at 24 Months | Stent thrombosis is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 24 months of index procedure |
| All Revascularizations at 30 Days | The 30-day revascularization rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 30 days of index procedure |
| All Revascularizations at 6 Months | All revascularizations are presented as Kaplan-Meier estimated event rates at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 6 months of index procedure |
| All Revascularizations at 12 Months | All revascularizations are presented as Kaplan-Meier estimated event rates at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 12 months of index procedure |
| All Revascularizations at 24 Months | All revascularizations are presented as Kaplan-Meier estimated event rates at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 24 months of index procedure |
| Ischemia-Driven Target Vessel Revascularization (ID-TVR) at 30 Days | The ischemia-driven Target Vessel Revascularization at 30 days is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 30 days of index procedure |
| Ischemia-Driven Target Vessel Revascularization (ID-TVR) at 6 Months | The ischemia-driven Target Vessel Revascularization (ID-TVR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 6 months of index procedure |
| Ischemia-driven Target Vessel Revascularization (ID-TVR) at 12 Months | The ischemia-driven Target Vessel Revascularization (ID-TVR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 12 months of index procedure |
| Ischemia-driven Target Vessel Revascularization (ID-TVR) at 24 Months | The ischemia-driven Target Vessel Revascularization (ID-TVR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 24 months of index procedure |
| Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 30 Days | The ischemia-driven Target Lesion Revascularization (ID-TLR) 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 30 days of index procedure |
| Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 6 Months | The ischemia-driven Target Lesion Revascularization (ID-TLR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 6 months of index procedure |
| Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 12 Months | The ischemia-driven Target Lesion Revascularization (ID-TLR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 12 months of index procedure |
| Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 24 Months | The ischemia-driven Target Lesion Revascularization (ID-TLR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 24 months of index procedure |
| Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 30 Days | The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 30 days of index procedure |
| Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 6 Months | The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 6 months of index procedure |
| Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 12 Months | The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 12 months of index procedure |
| Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 24 Months | The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 24 months of index procedure |
| Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 30 Days | The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 30 days of index procedure |
| Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 6 Months | The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 6 months of index procedure |
| Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 12 Months | The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 12 months of index procedure |
| Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 24 Months | The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 24 months of index procedure |
| Procedural MI at 30 Days | The procedural MI 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 30 days of index procedure |
| Procedural MI at 6 Months | The procedural MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 6 months of index procedure |
| Procedural MI at 12 Months | The procedural MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 12 months of index procedure |
| Procedural MI at 24 Months | The procedural MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 24 months of index procedure |
| Non-Procedural MI at 30 Days | The non-procedural MI 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 30 days of index procedure |
| Non-Procedural MI at 6 Months | The non-procedural MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 6 months of index procedure |
| Non-Procedural MI at 12 Months | The non-procedural MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 12 months of index procedure |
| Non-Procedural MI at 24 Months | The non-procedural MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 24 months of index procedure |
| Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 30 Days | The 30-day rate of MI using the Fourth Universal Definition of MI is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 30 days of index procedure |
| Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 6 Months | MI using the Fourth Universal Definition of MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 6 months of index procedure |
| Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 12 Months | MI using the Fourth Universal Definition of MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 12 months of index procedure |
| Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 24 Months | MI using the Fourth Universal Definition of MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 24 months of index procedure |
| Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 30 Days | The 30-day rate of MI using the SCAI Definition of MI is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 30 days of index procedure |
| Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 6 Months | MI using the SCAI definition is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 6 months of index procedure |
| Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 12 Months | MI using the SCAI definition is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 12 months of index procedure |
| Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 24 Months | MI using the SCAI definition is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | within 24 months of index procedure |
| Sapporo |
| Hokkaido |
| 065-0033 |
| Japan |
| Sakurakai Takahashi Hospital | Kobe | Hyōgo | 654-0026 | Japan |
| Higashi-Takarazuka Satoh Hospital | Takarazuka | Hyōgo | 665-0873 | Japan |
| Shonan-Kamakura General Hospital | Kamakura | Kanagawa | 247-8533 | Japan |
| Johas Kanto Rosai Hospital | Kawasaki | Kanagawa | 211-8510 | Japan |
| Kyoto-Katsura Hospital | Kyoto | Kyoto | 615-8256 | Japan |
| Miyazaki Medical Association Hospital | Miyazaki | Miyazaki | 880-2102 | Japan |
| Derived |
| Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3. |
The Intent to Treat (ITT) population was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. Data on the ITT population was collected through 30 days for primary endpoints. Long-term follow-up for the ITT population to 24 months is complete.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Percentage of Subjects With Procedural Success | 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 | ITT population was the primary analysis cohort; data on roll-in subjects was only collected through 30 days. Data collected from the roll-in subjects were not pre-specified to be reported as a Primary or Secondary Outcome Measure; therefore, only the ITT arm is reported. The ITT population includes all subjects enrolled in the pivotal phase of the study. This population does not include roll-in subjects. | Posted | Number | percentage of participants | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure |
|
|
|
| Secondary | Number of Participants With Device Crossing Success | 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. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat group is reported. | Posted | Count of Participants | Participants | At end of procedure, with a mean total procedure time of 62.5 minutes |
|
|
|
| Secondary | Number of Participants With Angiographic Success (Residual Stenosis <50%) | 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. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Count of Participants | Participants | At end of procedure, with a mean total procedure time of 62.5 minutes |
|
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| Secondary | Number of Participants With Procedural Success (Residual Stenosis <=30%) | 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. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Count of Participants | Participants | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure |
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| Secondary | Number of Participants With Angiographic Success (Residual Stenosis <=30%) | 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. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Count of Participants | Participants | At end of procedure, with a mean total procedure time of 62.5 minutes |
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| Secondary | Number of Participants With Serious Angiographic Complications | 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. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Count of Participants | Participants | At end of procedure, with a mean total procedure time of 62.5 minutes |
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| Secondary | MACE Rate at 6 Months | 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. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 6 months of index procedure |
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| Secondary | MACE Rate at 12 Months | 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. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 12 months of index procedure |
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| Secondary | MACE Rate at 24 Months | 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. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 24 months of index procedure |
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| Secondary | Target Lesion Failure (TLF) at 30 Days | 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. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | Within 30 days of index procedure |
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| Secondary | Target Lesion Failure (TLF) at 6 Months | 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. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | Within 6 months of index procedure |
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| Secondary | Target Lesion Failure (TLF) at 12 Months | 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 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | Within 12 months of index procedure |
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| Secondary | Target Lesion Failure (TLF) at 24 Months | 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 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | Within 24 months of index procedure |
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| Secondary | All-Cause Death at 30 Days | The 30-day rates of all-cause death are presented as proportions. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | Within 30 days from index procedure |
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| Secondary | All-Cause Death at 6 Months | All-cause death at 6 months is presented as Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 6 months of index procedure |
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| Secondary | All-Cause Death at 12 Months | All-cause death at 12 month is presented as Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 12 months of procedure |
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| Secondary | All-Cause Death at 24 Months | All-cause death at 24 month is presented as Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 24 months of procedure |
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| Secondary | Myocardial Infarction (MI) at 30 Days | The 30-day MI rates are presented as proportions. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 30 days of index procedure |
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| Secondary | Myocardial Infarction (MI) at 6 Months | MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | Within 6 months of index procedure |
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| Secondary | Myocardial Infarction (MI) at 12 Months | MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | Within 12 months of index procedure |
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| Secondary | Myocardial Infarction (MI) at 24 Months | MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | Within 24 months of index procedure |
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| Secondary | Myocardial Infarction Attributable to Target Vessel (TV-MI) at 30 Days | The Myocardial Infarction attributable to the target vessel (TV-MI) rates at 30 days are presented as proportions. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 30 days of index procedure |
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| Secondary | Myocardial Infarction Attributable to Target Vessel (TV-MI) at 6 Months | The Myocardial Infarction attributable to the target vessel (TV-MI) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | Within 6 month of index procedure |
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| Secondary | Myocardial Infarction Attributable to Target Vessel (TV-MI) at 12 Months | The Myocardial Infarction attributable to the target vessel (TV-MI) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | Within 12 months of index procedure |
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| Secondary | Myocardial Infarction Attributable to Target Vessel (TV-MI) at 24 Months | The Myocardial Infarction attributable to the target vessel (TV-MI) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | Within 24 months of index procedure |
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| Secondary | Stent Thrombosis at 30 Days | The Stent Thrombosis rate at 30 days is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | Within 30 days of index procedure |
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| Secondary | Stent Thrombosis at 6 Months | Stent thrombosis is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 6 months of index procedure |
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| Secondary | Stent Thrombosis at 12 Months | Stent thrombosis is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 12 months of index procedure |
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| Secondary | Stent Thrombosis at 24 Months | Stent thrombosis is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 24 months of index procedure |
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| Secondary | All Revascularizations at 30 Days | The 30-day revascularization rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 30 days of index procedure |
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| Secondary | All Revascularizations at 6 Months | All revascularizations are presented as Kaplan-Meier estimated event rates at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 6 months of index procedure |
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| Secondary | All Revascularizations at 12 Months | All revascularizations are presented as Kaplan-Meier estimated event rates at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 12 months of index procedure |
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| Secondary | All Revascularizations at 24 Months | All revascularizations are presented as Kaplan-Meier estimated event rates at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 24 months of index procedure |
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| Secondary | Ischemia-Driven Target Vessel Revascularization (ID-TVR) at 30 Days | The ischemia-driven Target Vessel Revascularization at 30 days is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 30 days of index procedure |
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| Secondary | Ischemia-Driven Target Vessel Revascularization (ID-TVR) at 6 Months | The ischemia-driven Target Vessel Revascularization (ID-TVR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 6 months of index procedure |
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| Secondary | Ischemia-driven Target Vessel Revascularization (ID-TVR) at 12 Months | The ischemia-driven Target Vessel Revascularization (ID-TVR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 12 months of index procedure |
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| Secondary | Ischemia-driven Target Vessel Revascularization (ID-TVR) at 24 Months | The ischemia-driven Target Vessel Revascularization (ID-TVR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 24 months of index procedure |
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| Secondary | Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 30 Days | The ischemia-driven Target Lesion Revascularization (ID-TLR) 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 30 days of index procedure |
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| Secondary | Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 6 Months | The ischemia-driven Target Lesion Revascularization (ID-TLR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 6 months of index procedure |
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| Secondary | Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 12 Months | The ischemia-driven Target Lesion Revascularization (ID-TLR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 12 months of index procedure |
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| Secondary | Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 24 Months | The ischemia-driven Target Lesion Revascularization (ID-TLR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 24 months of index procedure |
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| Secondary | Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 30 Days | The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 30 days of index procedure |
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| Secondary | Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 6 Months | The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 6 months of index procedure |
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| Secondary | Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 12 Months | The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 12 months of index procedure |
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| Secondary | Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 24 Months | The non-ischemia-driven Target Vessel Revascularization (Non-ID-TVR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 24 months of index procedure |
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| Secondary | Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 30 Days | The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 30 days of index procedure |
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| Secondary | Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 6 Months | The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 6 months of index procedure |
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| Secondary | Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 12 Months | The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 12 months of index procedure |
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| Secondary | Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 24 Months | The non-ischemia-driven Target Lesion Revascularization (Non-ID-TLR) is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 24 months of index procedure |
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| Secondary | Procedural MI at 30 Days | The procedural MI 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 30 days of index procedure |
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| Secondary | Procedural MI at 6 Months | The procedural MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 6 months of index procedure |
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| Secondary | Procedural MI at 12 Months | The procedural MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 12 months of index procedure |
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| Secondary | Procedural MI at 24 Months | The procedural MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 24 months of index procedure |
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| Secondary | Non-Procedural MI at 30 Days | The non-procedural MI 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 30 days of index procedure |
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| Secondary | Non-Procedural MI at 6 Months | The non-procedural MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 6 months of index procedure |
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| Secondary | Non-Procedural MI at 12 Months | The non-procedural MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 12 months of index procedure |
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| Secondary | Non-Procedural MI at 24 Months | The non-procedural MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 24 months of index procedure |
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| Secondary | Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 30 Days | The 30-day rate of MI using the Fourth Universal Definition of MI is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 30 days of index procedure |
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| Secondary | Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 6 Months | MI using the Fourth Universal Definition of MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 6 months of index procedure |
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| Secondary | Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 12 Months | MI using the Fourth Universal Definition of MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 12 months of index procedure |
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| Secondary | Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 24 Months | MI using the Fourth Universal Definition of MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 24 months of index procedure |
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| Secondary | Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 30 Days | The 30-day rate of MI using the SCAI Definition of MI is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 30 days of index procedure |
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| Secondary | Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 6 Months | MI using the SCAI definition is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 6 months of index procedure |
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| Secondary | Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 12 Months | MI using the SCAI definition is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 12 months of index procedure |
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| Secondary | Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 24 Months | MI using the SCAI definition is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set. | Data collected from the roll-in subjects were not pre-specified to be reported as a Secondary Outcome Measure; therefore, only the Intent To Treat population is reported. | Posted | Number | percentage of participants | within 24 months of index procedure |
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|
| 0 |
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | Coronary IVL System(ITT) Through 30Days | Adverse events reported through 30 days post-procedure for ITT subjects. The ITT analysis set was the primary analysis cohort used to assess the primary safety and effectiveness endpoints. | 0 | 64 | 5 | 64 | 11 | 64 |
| EG002 | Coronary IVL System(ITT) Through 12Months | Adverse events reported through 12 months post-procedure for ITT subjects. Adverse event data on ITT subjects was collected through12 months for long-term follow-up. Long-term follow-up for ITT subjects to 24 months is complete. | 0 | 64 | 23 | 64 | 14 | 64 |
| EG003 | Coronary IVL System (ITT) Through 24 Months | Adverse events reported through 24 months post-procedure for ITT subjects. Adverse event data on ITT subjects was collected through 24 months for long-term follow-up. Long-term follow-up for ITT subjects to 24 months is complete. | 2 | 64 | 30 | 64 | 14 | 64 |
| Myocardial Infarction | Cardiac disorders | MedDRA version 21.1 | Systematic Assessment |
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| Retroperitoneal Mass | Gastrointestinal disorders | MedDRA version 21.1 | Systematic Assessment |
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| Periodontitis | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA version 21.1 | Systematic Assessment |
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| Peripheral arterial occlusive disease | Vascular disorders | MedDRA version 21.1 | Systematic Assessment |
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| Myocardial ischemia | Cardiac disorders | MedDRA version 21.1 | Systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA version 21.1 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA version 21.1 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA version 21.1 | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | MedDRA version 21.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA version 21.1 | Systematic Assessment |
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| Large Intestine Polyp | Gastrointestinal disorders | MedDRA version 21.1 | Systematic Assessment |
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| Mechanical ileus | Gastrointestinal disorders | MedDRA version 21.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Infected dermal cyst | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Pelvic abscess | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Systematic Assessment |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Systematic Assessment |
|
| Pancreatic neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Peripheral ischemia | Vascular disorders | MedDRA version 21.1 | Systematic Assessment |
|
|
| Vascular Access Site Complication | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment | ITT group does not meet 5% frequency threshold for reporting |
|
| Hypotension | Vascular disorders | MedDRA version 21.1 | Systematic Assessment | ITT group does not meet 5% frequency threshold for reporting |
|
| Constipation | Gastrointestinal disorders | MedDRA version 21.1 | Systematic Assessment | Roll-In and ITT groups do not meet the 5% frequency threshold for reporting |
|
Not provided
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |