Trial Outcomes & Findings for Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO) (NCT NCT05966662)

NCT ID: NCT05966662

Last Updated: 2026-01-28

Results Overview

Freedom from MACE within 30 days of the index procedure. MACE is defined as a composite occurrence of: cardiac death, myocardial infarction (MI), target vessel revascularization (TVR) after the completion of the index procedure.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 145 participants
• Primary outcome timeframe: within 30 days of index procedure
• Results posted on: 2026-01-28

Participant Flow

Participant milestones

Measure	Intent to Treat Data analyzed from all enrolled participants through 30 days.
Overall Study STARTED	145
Overall Study COMPLETED	145
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)

Baseline characteristics by cohort

Measure	Single-Arm n=145 Participants Subjects with de novo, calcified coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI). IVL with Shockwave C2+ 2Hz Coronary IVL Catheter: Lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.
Age, Continuous Mean	70.5 years STANDARD_DEVIATION 9.0 • n=158 Participants
Sex: Female, Male Female	46 Participants n=158 Participants
Sex: Female, Male Male	99 Participants n=158 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=158 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	134 Participants n=158 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=158 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=158 Participants
Race/Ethnicity, Customized Asian	9 Participants n=158 Participants
Race/Ethnicity, Customized Black or African American	9 Participants n=158 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=158 Participants
Race/Ethnicity, Customized White	120 Participants n=158 Participants
Race/Ethnicity, Customized Unknown/ Not specified	1 Participants n=158 Participants
Race/Ethnicity, Customized Other	5 Participants n=158 Participants
Body Mass Index	29.3 kg/m^2 STANDARD_DEVIATION 6.4 • n=158 Participants
BMI Categories 1 Underweight	1 Participants n=158 Participants
BMI Categories 1 Healthy weight	33 Participants n=158 Participants
BMI Categories 1 Overweight	55 Participants n=158 Participants
BMI Categories 1 Obesity	56 Participants n=158 Participants

PRIMARY outcome

Timeframe: within 30 days of index procedure

Population: One (1) subject experienced device delivery failure and was not included in the analysis.

Freedom from MACE within 30 days of the index procedure. MACE is defined as a composite occurrence of: cardiac death, myocardial infarction (MI), target vessel revascularization (TVR) after the completion of the index procedure.

Outcome measures

Measure	Intent to Treat n=144 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Percentage of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure	98.6 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: One (1) participant was not treated with the C2+ 2Hz catheter. Of those treated, one did not receive a stent during the index procedure and was not included in this analysis.

Procedural Success post stent delivery with a residual stenosis ≤30% (core laboratory assessed) and without in-hospital MACE.

Outcome measures

Measure	Intent to Treat n=143 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Percentage of Participants With Procedural Success (Residual Stenosis ≤30%)	97.9 Percentage of participants

SECONDARY outcome

Timeframe: at the end of procedure

Device Crossing Success is defined as the ability to deliver the IVL catheter across the target lesion, and delivery of lithotripsy without serious angiographic complications immediately after IVL.

Outcome measures

Measure	Intent to Treat n=145 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Number of Participants With Device Crossing Success	143 Participants

SECONDARY outcome

Timeframe: at the end of procedure

Population: One (1) participant was not included as they were missing final angiographic images for analysis

Angiographic Success defined as stent delivery with <50% residual stenosis and without serious angiographic complications.

Outcome measures

Measure	Intent to Treat n=144 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Number of Participants With Angiographic Success (Residual Stenosis <50%)	140 Participants

SECONDARY outcome

Timeframe: at the end of the procedure

Population: One (1) subject did not receive a stent during the index procedure and was not included in the analysis

Procedural Success defined as stent delivery with a residual stenosis <50% (core laboratory assessed) and without in-hospital MACE.

Outcome measures

Measure	Intent to Treat n=144 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Number of Participants With Procedural Success (Residual Stenosis <50% and Without In-hospital MACE)	141 Participants

SECONDARY outcome

Timeframe: at end of procedure

Population: One (1) participant was not included in the analysis as they were missing final angiographic images for analysis

Angiographic Success defined as stent delivery with ≤30% residual stenosis and without serious angiographic complications.

Outcome measures

Measure	Intent to Treat n=144 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Number of Participants With Angiographic Success (Residual Stenosis ≤30%)	140 Participants

SECONDARY outcome

Timeframe: at end of procedure

Population: One (1) subject was not included as they were missing final angiographic images for analysis

Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.

Outcome measures

Measure	Intent to Treat n=144 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Number of Participants With Serious Angiographic Complications	0 Participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Target lesion failure (TLF)is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. 30 day rates are presented as proportions.

Outcome measures

Measure	Intent to Treat n=145 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Target Lesion Failure Rate at 30 Days	0.7 Percentage of participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Percentage of participants who experienced death (all-cause) through 30 days post index procedure.

Outcome measures

Measure	Intent to Treat n=145 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
All-Cause Death Rate at 30 Days	0 Percentage of participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Percentage of participants who experienced cardiac death through 30 days post index procedure

Outcome measures

Measure	Intent to Treat n=145 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Cardiac Death Rate at 30 Days	0 Percentage of participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Percentage of participants who experienced myocardial infarction through 30 days post index procedure

Outcome measures

Measure	Intent to Treat n=145 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
MI Rate at 30 Days	0.7 Percentage of participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Percentage of participants who experienced MI attributable to the target vessel through 30 days post index procedure

Outcome measures

Measure	Intent to Treat n=145 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Target Vessel-MI (TV-MI) Rate at 30 Days	0.7 Percentage of participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Percentage of participants who experienced procedural myocardial infarction through 30 days post index procedure

Outcome measures

Measure	Intent to Treat n=145 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Procedural MI Rate at 30 Days	0.7 Percentage of Participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Percentage of participants who experienced Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition) through 30 days post index procedure

Outcome measures

Measure	Intent to Treat n=145 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Non-Procedural MI Rate at 30 Days	0 Percentage of participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Percentage of participants who experienced a Ischemia-Driven Target Vessel Revascularization through 30-days post index procedure

Outcome measures

Measure	Intent to Treat n=145 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Ischemia Driven-Target Vessel Revascularization (ID-TVR) Rate at 30 Days	0 Percentage of Participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Percentage of participants who experienced a Ischemia-Driven Target Lesion Revascularization through 30-days post index procedure

Outcome measures

Measure	Intent to Treat n=145 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Ischemia-Driven Target Lesion Revascularization (ID-TLR) Rate at 30 Days	0 Percentage of Participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Percentage of participants who experienced a Non-Ischemia-Driven Target Vessel Revascularization through 30-days post index procedure

Outcome measures

Measure	Intent to Treat n=145 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) Rate at 30 Days	0 Percentage of Participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Percentage of participants who experienced a Non-Ischemia-Driven Target Lesion Revascularization through 30-days post index procedure

Outcome measures

Measure	Intent to Treat n=145 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Non-ID-TLR Rate at 30 Days	0.7 Percentage of Participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Percentage of participants who experienced any revascularizations (ID and non-ID) through 30 days post index procedure.

Outcome measures

Measure	Intent to Treat n=145 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Any Revascularizations Rate at 30 Days	4.1 Percentage of Participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Percentage of participants who experienced any stent thrombosis (definite, probable, definite or probable) through 30 days post index procedure.

Outcome measures

Measure	Intent to Treat n=145 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Stent Thrombosis Rate at 30 Days	0 Percentage of Participants

SECONDARY outcome

Timeframe: within 30 days of index procedure

Percentage of participants who experienced MI using the 4th Universal Definition through 30 days post index procedure.

Outcome measures

Measure	Intent to Treat n=145 Participants Data on enrolled participants was collected through 30-days for secondary endpoints.
Rate of MI Using the 4th Universal Definition at 30 Days	7.6 Percentage of Participants

Adverse Events

Intent to Treat (ITT)

Serious events: 13 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intent to Treat (ITT) n=145 participants at risk Adverse Events through 30 Days including all cause mortality, serious adverse events and non-serious adverse events that exceeded a 2.5% threshold.
Injury, poisoning and procedural complications Plaque shift	1.4% 2/145 • Number of events 2 • 30 days All Adverse events were summarized overall for the Intent to Treat population through 30-days of index procedure.
Investigations Influenza virus test positive	0.69% 1/145 • Number of events 1 • 30 days All Adverse events were summarized overall for the Intent to Treat population through 30-days of index procedure.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.69% 1/145 • Number of events 1 • 30 days All Adverse events were summarized overall for the Intent to Treat population through 30-days of index procedure.
Vascular disorders Hypertension	0.69% 1/145 • Number of events 1 • 30 days All Adverse events were summarized overall for the Intent to Treat population through 30-days of index procedure.
Cardiac disorders Atrial fibrillation	0.69% 1/145 • Number of events 2 • 30 days All Adverse events were summarized overall for the Intent to Treat population through 30-days of index procedure.
Cardiac disorders Cardiac failure acute	1.4% 2/145 • Number of events 2 • 30 days All Adverse events were summarized overall for the Intent to Treat population through 30-days of index procedure.
Cardiac disorders Acute myocardial infarction	0.69% 1/145 • Number of events 1 • 30 days All Adverse events were summarized overall for the Intent to Treat population through 30-days of index procedure.
Cardiac disorders Arrhythmia	0.69% 1/145 • Number of events 1 • 30 days All Adverse events were summarized overall for the Intent to Treat population through 30-days of index procedure.
Cardiac disorders Coronary artery dissection	0.69% 1/145 • Number of events 1 • 30 days All Adverse events were summarized overall for the Intent to Treat population through 30-days of index procedure.
Cardiac disorders Coronary artery perforation	0.69% 1/145 • Number of events 1 • 30 days All Adverse events were summarized overall for the Intent to Treat population through 30-days of index procedure.
Cardiac disorders Ventricular fibrillation	0.69% 1/145 • Number of events 1 • 30 days All Adverse events were summarized overall for the Intent to Treat population through 30-days of index procedure.
Gastrointestinal disorders Nausea	0.69% 1/145 • Number of events 1 • 30 days All Adverse events were summarized overall for the Intent to Treat population through 30-days of index procedure.
General disorders Non-cardiac chest pain	0.69% 1/145 • Number of events 1 • 30 days All Adverse events were summarized overall for the Intent to Treat population through 30-days of index procedure.

Other adverse events

Measure	Intent to Treat (ITT) n=145 participants at risk Adverse Events through 30 Days including all cause mortality, serious adverse events and non-serious adverse events that exceeded a 2.5% threshold.
Cardiac disorders Coronary artery dissection	2.8% 4/145 • Number of events 4 • 30 days All Adverse events were summarized overall for the Intent to Treat population through 30-days of index procedure.
Injury, poisoning and procedural complications Plaque shift	3.4% 5/145 • Number of events 6 • 30 days All Adverse events were summarized overall for the Intent to Treat population through 30-days of index procedure.

Additional Information

Tracy Courtney

Shockwave Medical

Phone: 1.650.224.7699

Email: TCourtn4@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding study results for a period that is more than 45 days but less than or equal to 90 days from the date that the communication is submitted to the sponsor for review. The sponsor cannot unilaterally extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER