Trial Outcomes & Findings for Disrupt CAD IV With the Shockwave Coronary IVL System (NCT NCT04151628)

NCT ID: NCT04151628

Last Updated: 2023-05-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 72 participants
• Primary outcome timeframe: Within 30 days of index procedure
• Results posted on: 2023-05-22

Participant Flow

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

72 subjects were consented and enrolled into the study

Participant milestones

Measure	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.	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.
Overall Study STARTED	8	64
Overall Study COMPLETED	8	64
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Disrupt CAD IV With the Shockwave Coronary IVL System

Baseline characteristics by cohort

Measure	Roll-in n=8 Participants 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.	Intent to Treat (ITT) n=64 Participants 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.	Total n=72 Participants Total of all reporting groups
Age, Continuous	73.3 years STANDARD_DEVIATION 3.5 • n=5 Participants	75.0 years STANDARD_DEVIATION 8.0 • n=7 Participants	74.8 years STANDARD_DEVIATION 7.7 • n=5 Participants
Age, Customized	72.5 years n=5 Participants	74.5 years n=7 Participants	73.5 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	16 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	48 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	64 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	63 Participants n=7 Participants	71 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Japan	8 participants n=5 Participants	64 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 30 days of index procedure

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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Percentage of Participants Who Experienced Freedom From MACE Within 30 Days Post-procedure	93.8 percentage of participants

PRIMARY outcome

Timeframe: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure

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.

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

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Percentage of Subjects With Procedural Success	93.8 percentage of participants

SECONDARY outcome

Timeframe: At end of procedure, with a mean total procedure time of 62.5 minutes

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Number of Participants With Device Crossing Success	63 Participants

SECONDARY outcome

Timeframe: At end of procedure, with a mean total procedure time of 62.5 minutes

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Number of Participants With Angiographic Success (Residual Stenosis <50%)	63 Participants

SECONDARY outcome

Timeframe: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Number of Participants With Procedural Success (Residual Stenosis <=30%)	60 Participants

SECONDARY outcome

Timeframe: At end of procedure, with a mean total procedure time of 62.5 minutes

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Number of Participants With Angiographic Success (Residual Stenosis <=30%)	63 Participants

SECONDARY outcome

Timeframe: At end of procedure, with a mean total procedure time of 62.5 minutes

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Number of Participants With Serious Angiographic Complications	63 Participants

SECONDARY outcome

Timeframe: within 6 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
MACE Rate at 6 Months	7.8 percentage of participants

SECONDARY outcome

Timeframe: within 12 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
MACE Rate at 12 Months	9.4 percentage of participants

SECONDARY outcome

Timeframe: within 24 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
MACE Rate at 24 Months	12.6 percentage of participants

SECONDARY outcome

Timeframe: Within 30 days of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Target Lesion Failure (TLF) at 30 Days	6.3 percentage of participants

SECONDARY outcome

Timeframe: Within 6 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Target Lesion Failure (TLF) at 6 Months	6.3 percentage of participants

SECONDARY outcome

Timeframe: Within 12 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Target Lesion Failure (TLF) at 12 Months	6.3 percentage of participants

SECONDARY outcome

Timeframe: Within 24 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Target Lesion Failure (TLF) at 24 Months	7.8 percentage of participants

SECONDARY outcome

Timeframe: Within 30 days from index procedure

Population: 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.

The 30-day rates of all-cause death are presented as proportions. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
All-Cause Death at 30 Days	0 percentage of participants

SECONDARY outcome

Timeframe: within 6 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
All-Cause Death at 6 Months	0 percentage of participants

SECONDARY outcome

Timeframe: within 12 months of procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
All-Cause Death at 12 Months	0 percentage of participants

SECONDARY outcome

Timeframe: within 24 months of procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
All-Cause Death at 24 Months	3.1 percentage of participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Population: 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.

The 30-day MI rates are presented as proportions. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Myocardial Infarction (MI) at 30 Days	6.3 percentage of participants

SECONDARY outcome

Timeframe: Within 6 months of index procedure

Population: 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.

MI is presented as Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Myocardial Infarction (MI) at 6 Months	6.3 percentage of participants

SECONDARY outcome

Timeframe: Within 12 months of index procedure

Population: 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.

MI is presented as Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Myocardial Infarction (MI) at 12 Months	6.3 percentage of participants

SECONDARY outcome

Timeframe: Within 24 months of index procedure

Population: 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.

MI is presented as Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Myocardial Infarction (MI) at 24 Months	6.3 percentage of participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Myocardial Infarction Attributable to Target Vessel (TV-MI) at 30 Days	6.3 percentage of participants

SECONDARY outcome

Timeframe: Within 6 month of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Myocardial Infarction Attributable to Target Vessel (TV-MI) at 6 Months	6.3 percentage of participants

SECONDARY outcome

Timeframe: Within 12 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Myocardial Infarction Attributable to Target Vessel (TV-MI) at 12 Months	6.3 percentage of participants

SECONDARY outcome

Timeframe: Within 24 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Myocardial Infarction Attributable to Target Vessel (TV-MI) at 24 Months	6.3 percentage of participants

SECONDARY outcome

Timeframe: Within 30 days of index procedure

Population: 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.

The Stent Thrombosis rate at 30 days is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Stent Thrombosis at 30 Days	0 percentage of participants

SECONDARY outcome

Timeframe: within 6 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Stent Thrombosis at 6 Months	0 percentage of participants

SECONDARY outcome

Timeframe: within 12 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Stent Thrombosis at 12 Months	0 percentage of participants

SECONDARY outcome

Timeframe: within 24 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Stent Thrombosis at 24 Months	0 percentage of participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Population: 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.

The 30-day revascularization rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
All Revascularizations at 30 Days	0 percentage of participants

SECONDARY outcome

Timeframe: within 6 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
All Revascularizations at 6 Months	12.5 percentage of participants

SECONDARY outcome

Timeframe: within 12 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
All Revascularizations at 12 Months	15.6 percentage of participants

SECONDARY outcome

Timeframe: within 24 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
All Revascularizations at 24 Months	20.4 percentage of participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Ischemia-Driven Target Vessel Revascularization (ID-TVR) at 30 Days	0 percentage of participants

SECONDARY outcome

Timeframe: within 6 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Ischemia-Driven Target Vessel Revascularization (ID-TVR) at 6 Months	3.1 percentage of participants

SECONDARY outcome

Timeframe: within 12 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Ischemia-driven Target Vessel Revascularization (ID-TVR) at 12 Months	4.7 percentage of participants

SECONDARY outcome

Timeframe: within 24 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Ischemia-driven Target Vessel Revascularization (ID-TVR) at 24 Months	7.9 percentage of participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 30 Days	0 percentage of participants

SECONDARY outcome

Timeframe: within 6 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 6 Months	1.6 percentage of participants

SECONDARY outcome

Timeframe: within 12 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 12 Months	1.6 percentage of participants

SECONDARY outcome

Timeframe: within 24 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Ischemia-Driven Target Lesion Revascularization (ID-TLR) at 24 Months	3.2 percentage of participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 30 Days	0 percentage of participants

SECONDARY outcome

Timeframe: within 6 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 6 Months	0 percentage of participants

SECONDARY outcome

Timeframe: within 12 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 12 Months	0 percentage of participants

SECONDARY outcome

Timeframe: within 24 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) at 24 Months	0 percentage of participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 30 Days	0 percentage of participants

SECONDARY outcome

Timeframe: within 6 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 6 Months	0 percentage of participants

SECONDARY outcome

Timeframe: within 12 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 12 Months	0 percentage of participants

SECONDARY outcome

Timeframe: within 24 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Non-Ischemia-Driven Target Lesion Revascularization (Non-ID-TLR) at 24 Months	0 percentage of participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Population: 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.

The procedural MI 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Procedural MI at 30 Days	6.3 percentage of participants

SECONDARY outcome

Timeframe: within 6 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Procedural MI at 6 Months	6.3 percentage of participants

SECONDARY outcome

Timeframe: within 12 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Procedural MI at 12 Months	6.3 percentage of participants

SECONDARY outcome

Timeframe: within 24 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Procedural MI at 24 Months	6.3 percentage of participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Population: 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.

The non-procedural MI 30-day rate is presented as a proportion. The secondary endpoints were analyzed using the Intent To Treat Analysis Set.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Non-Procedural MI at 30 Days	0 percentage of participants

SECONDARY outcome

Timeframe: within 6 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Non-Procedural MI at 6 Months	0 percentage of participants

SECONDARY outcome

Timeframe: within 12 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Non-Procedural MI at 12 Months	0 percentage of participants

SECONDARY outcome

Timeframe: within 24 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Non-Procedural MI at 24 Months	0 percentage of participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 30 Days	7.8 percentage of participants

SECONDARY outcome

Timeframe: within 6 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 6 Months	7.8 percentage of participants

SECONDARY outcome

Timeframe: within 12 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 12 Months	7.8 percentage of participants

SECONDARY outcome

Timeframe: within 24 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Myocardial Infarction (MI) Using the Fourth Universal Definition of MI, at 24 Months	7.8 percentage of participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 30 Days	3.1 percentage of participants

SECONDARY outcome

Timeframe: within 6 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 6 Months	3.1 percentage of participants

SECONDARY outcome

Timeframe: within 12 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 12 Months	3.1 percentage of participants

SECONDARY outcome

Timeframe: within 24 months of index procedure

Population: 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.

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.

Outcome measures

Measure	Intent To Treat n=64 Participants 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.
Myocardial Infarction (MI) Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition, at 24 Months	3.1 percentage of participants

Adverse Events

Coronary IVL System(Roll-In) Through 30Days

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Coronary IVL System(ITT) Through 30Days

Serious events: 5 serious events

Other events: 11 other events

Deaths: 0 deaths

Coronary IVL System(ITT) Through 12Months

Serious events: 23 serious events

Other events: 14 other events

Deaths: 0 deaths

Coronary IVL System (ITT) Through 24 Months

Serious events: 30 serious events

Other events: 14 other events

Deaths: 2 deaths

Serious adverse events

Measure	Coronary IVL System(Roll-In) Through 30Days n=8 participants at risk 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.	Coronary IVL System(ITT) Through 30Days n=64 participants at risk 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.	Coronary IVL System(ITT) Through 12Months n=64 participants at risk 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.	Coronary IVL System (ITT) Through 24 Months n=64 participants at risk 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.
Cardiac disorders Coronary Artery Occlusion	0.00% 0/8 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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	3.1% 2/64 • Number of events 2 • 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
Cardiac disorders Myocardial Infarction	0.00% 0/8 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Gastrointestinal disorders Retroperitoneal Mass	0.00% 0/8 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Infections and infestations Periodontitis	0.00% 0/8 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Nervous system disorders Cerebrovascular accident	0.00% 0/8 • 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	1.6% 1/64 • Number of events 1 • 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	3.1% 2/64 • Number of events 2 • 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	4.7% 3/64 • Number of events 3 • 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
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/8 • 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	1.6% 1/64 • Number of events 1 • 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	3.1% 2/64 • Number of events 2 • 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	3.1% 2/64 • Number of events 2 • 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
Cardiac disorders Myocardial ischemia	0.00% 0/8 • 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	0.00% 0/64 • 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	3.1% 2/64 • Number of events 2 • 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	3.1% 2/64 • Number of events 2 • 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
Cardiac disorders Angina Pectoris	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	3.1% 2/64 • Number of events 2 • 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
Cardiac disorders Angina unstable	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Cardiac disorders Arrhythmia	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	3.1% 2/64 • Number of events 2 • 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
Cardiac disorders Cardiac Failure Congestive	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	3.1% 2/64 • Number of events 2 • 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
Ear and labyrinth disorders Vertigo	0.00% 0/8 • 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	0.00% 0/64 • 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	3.1% 2/64 • Number of events 2 • 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	3.1% 2/64 • Number of events 2 • 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
Gastrointestinal disorders Large Intestine Polyp	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Gastrointestinal disorders Mechanical ileus	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 2 • 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
General disorders Oedema peripheral	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Hepatobiliary disorders Cholecystitis	0.00% 0/8 • 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	0.00% 0/64 • 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	3.1% 2/64 • Number of events 3 • 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	3.1% 2/64 • Number of events 3 • 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
Hepatobiliary disorders Bile duct stone	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 2 • 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
Hepatobiliary disorders Jaundice	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Infections and infestations Cellulitis	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Infections and infestations Infected dermal cyst	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Infections and infestations Pelvic abscess	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Infections and infestations Pneumonia	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neuroendocrine tumour	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Vascular disorders Haemorrhage	0.00% 0/8 • 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	0.00% 0/64 • 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	3.1% 2/64 • Number of events 2 • 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	3.1% 2/64 • Number of events 2 • 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
Vascular disorders Aortic stenosis	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 1 • 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
Vascular disorders Peripheral ischemia	0.00% 0/8 • 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	0.00% 0/64 • 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	1.6% 1/64 • Number of events 1 • 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	1.6% 1/64 • Number of events 3 • 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

Other adverse events

Measure	Coronary IVL System(Roll-In) Through 30Days n=8 participants at risk 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.	Coronary IVL System(ITT) Through 30Days n=64 participants at risk 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.	Coronary IVL System(ITT) Through 12Months n=64 participants at risk 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.	Coronary IVL System (ITT) Through 24 Months n=64 participants at risk 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.
Cardiac disorders Coronary artery dissection	0.00% 0/8 • 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	17.2% 11/64 • Number of events 11 • 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	18.8% 12/64 • Number of events 12 • 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	18.8% 12/64 • Number of events 12 • 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
Injury, poisoning and procedural complications Vascular Access Site Complication	12.5% 1/8 • Number of events 1 • 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	3.1% 2/64 • Number of events 2 • 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	3.1% 2/64 • Number of events 2 • 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	3.1% 2/64 • Number of events 2 • 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
Vascular disorders Hypotension	12.5% 1/8 • Number of events 1 • 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	3.1% 2/64 • Number of events 2 • 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	3.1% 2/64 • Number of events 2 • 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	3.1% 2/64 • Number of events 2 • 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
Gastrointestinal disorders Constipation	0.00% 0/8 • 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	1.6% 1/64 • Number of events 1 • 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	6.2% 4/64 • Number of events 4 • 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	6.2% 4/64 • Number of events 4 • 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

Additional Information

Randee Randoll, Director Clinical Affairs

Shockwave Medical Inc

Phone: 1-408-577-7856

Email: rrandoll@shockwavemedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60