Trial Outcomes & Findings for Disrupt CAD III Post-Approval Study (PAS) (NCT NCT05021757)
NCT ID: NCT05021757
Last Updated: 2024-02-01
Results Overview
Recruitment status
COMPLETED
Target enrollment
1212 participants
Primary outcome timeframe
Up to hospital discharge, approximately 24-48 hours
Results posted on
2024-02-01
Participant Flow
Participant milestones
| Measure |
Disrupt CAD III PAS Cohort
Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.
Shockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter
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|---|---|
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Overall Study
STARTED
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1212
|
|
Overall Study
COMPLETED
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1212
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|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data is Unknown or Not Reported for some patients because Race is an optional field in the CathPCI registry data collection form.
Baseline characteristics by cohort
| Measure |
Disrupt CAD III PAS Cohort
n=1212 Participants
Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.
Shockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter
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|---|---|
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Age, Continuous
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73.4 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
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330 Participants
n=5 Participants
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Sex: Female, Male
Male
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882 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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2 Participants
n=5 Participants • Data is Unknown or Not Reported for some patients because Race is an optional field in the CathPCI registry data collection form.
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|
Race (NIH/OMB)
Asian
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36 Participants
n=5 Participants • Data is Unknown or Not Reported for some patients because Race is an optional field in the CathPCI registry data collection form.
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|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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2 Participants
n=5 Participants • Data is Unknown or Not Reported for some patients because Race is an optional field in the CathPCI registry data collection form.
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Race (NIH/OMB)
Black or African American
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68 Participants
n=5 Participants • Data is Unknown or Not Reported for some patients because Race is an optional field in the CathPCI registry data collection form.
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|
Race (NIH/OMB)
White
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1060 Participants
n=5 Participants • Data is Unknown or Not Reported for some patients because Race is an optional field in the CathPCI registry data collection form.
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Race (NIH/OMB)
More than one race
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2 Participants
n=5 Participants • Data is Unknown or Not Reported for some patients because Race is an optional field in the CathPCI registry data collection form.
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Race (NIH/OMB)
Unknown or Not Reported
|
42 Participants
n=5 Participants • Data is Unknown or Not Reported for some patients because Race is an optional field in the CathPCI registry data collection form.
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Region of Enrollment
United States
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1212 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to hospital discharge, approximately 24-48 hoursOutcome measures
| Measure |
Disrupt CAD III PAS Cohort
n=1212 Participants
Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.
Shockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter
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|---|---|
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All-cause Death Rate
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3 Participants
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PRIMARY outcome
Timeframe: Up to hospital discharge, approximately 24-48 hoursOutcome measures
| Measure |
Disrupt CAD III PAS Cohort
n=1212 Participants
Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.
Shockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter
|
|---|---|
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Number of Participants With Procedure-related Adverse Events
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35 Participants
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PRIMARY outcome
Timeframe: Up to hospital discharge, approximately 24-48 hoursPopulation: Information on IVL-specific data points were collected on a separate optional IVL Auxiliary data collection form in the CathPCI Registry. There were 153 subjects in the PAS cohort with available IVL Auxiliary data.
Outcome measures
| Measure |
Disrupt CAD III PAS Cohort
n=153 Participants
Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.
Shockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter
|
|---|---|
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Number of Participants With IVL-related Ventricular Arrhythmia
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0 Participants
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PRIMARY outcome
Timeframe: Up to hospital discharge, approximately 24-48 hoursPopulation: Information on IVL-specific data points were collected on a separate optional IVL Auxiliary data collection form in the CathPCI Registry. There were 153 subjects in the PAS cohort with available IVL Auxiliary data.
Outcome measures
| Measure |
Disrupt CAD III PAS Cohort
n=153 Participants
Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.
Shockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter
|
|---|---|
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Number of Participants With IVL Balloon Loss of Pressure/Rupture
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2 Participants
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PRIMARY outcome
Timeframe: Up to hospital discharge, approximately 24-48 hoursPopulation: Information on IVL-specific data points were collected on a separate optional IVL Auxiliary data collection form in the CathPCI Registry. There were 153 subjects in the PAS cohort with available IVL Auxiliary data.
Outcome measures
| Measure |
Disrupt CAD III PAS Cohort
n=153 Participants
Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.
Shockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter
|
|---|---|
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Number of Participants With Serious Coronary Dissection Following Balloon Loss of Pressure/Rupture
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0 Participants
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PRIMARY outcome
Timeframe: Up to hospital discharge, approximately 24-48 hoursPopulation: Information on IVL-specific data points in PPM/ICD patients were collected on a separate optional IVL Auxiliary data collection form in the CathPCI Registry. There were 12 subjects with PPM/ICD devices in the PAS cohort with available IVL Auxiliary data.
Events that may indicate an adverse device interaction including inappropriate inhibition of pacing during IVL device utilization, inappropriate ICD shock during IVL device utilization (for ICD patients only), and the need for device re-programming associated with IVL use (during or post procedure).
Outcome measures
| Measure |
Disrupt CAD III PAS Cohort
n=12 Participants
Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.
Shockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter
|
|---|---|
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Number of IVL-related Pacing Issues in Patients With PPM/ICD
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0 Participants
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Adverse Events
Disrupt CAD III PAS Cohort
Serious events: 35 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Disrupt CAD III PAS Cohort
n=1212 participants at risk
Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort. A minimum of 150 patients with 30-day follow-up will be included in the PAS cohort.
Shockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter
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|---|---|
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Cardiac disorders
Coronary Artery Perforation
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0.58%
7/1212 • Number of events 7 • Up to hospital discharge, approximately 24-48 hours
In the CathPCI registry data collection form, intra- and post-procedure adverse events are captured in a pre-specified list. Information on procedure and device-relatedness, as well as serious or non-serious designation, is not captured in the registry.
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Cardiac disorders
Significant Coronary Artery Dissection (C and above)
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0.41%
5/1212 • Number of events 5 • Up to hospital discharge, approximately 24-48 hours
In the CathPCI registry data collection form, intra- and post-procedure adverse events are captured in a pre-specified list. Information on procedure and device-relatedness, as well as serious or non-serious designation, is not captured in the registry.
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Injury, poisoning and procedural complications
Bleeding - Access Site
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0.17%
2/1212 • Number of events 2 • Up to hospital discharge, approximately 24-48 hours
In the CathPCI registry data collection form, intra- and post-procedure adverse events are captured in a pre-specified list. Information on procedure and device-relatedness, as well as serious or non-serious designation, is not captured in the registry.
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Gastrointestinal disorders
Bleeding - Gastrointestinal
|
0.08%
1/1212 • Number of events 1 • Up to hospital discharge, approximately 24-48 hours
In the CathPCI registry data collection form, intra- and post-procedure adverse events are captured in a pre-specified list. Information on procedure and device-relatedness, as well as serious or non-serious designation, is not captured in the registry.
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Injury, poisoning and procedural complications
Bleeding - Hematoma at Access Site
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0.25%
3/1212 • Number of events 3 • Up to hospital discharge, approximately 24-48 hours
In the CathPCI registry data collection form, intra- and post-procedure adverse events are captured in a pre-specified list. Information on procedure and device-relatedness, as well as serious or non-serious designation, is not captured in the registry.
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Injury, poisoning and procedural complications
Bleeding - Other
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0.08%
1/1212 • Number of events 1 • Up to hospital discharge, approximately 24-48 hours
In the CathPCI registry data collection form, intra- and post-procedure adverse events are captured in a pre-specified list. Information on procedure and device-relatedness, as well as serious or non-serious designation, is not captured in the registry.
|
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Injury, poisoning and procedural complications
Bleeding - Retroperitoneal
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0.17%
2/1212 • Number of events 2 • Up to hospital discharge, approximately 24-48 hours
In the CathPCI registry data collection form, intra- and post-procedure adverse events are captured in a pre-specified list. Information on procedure and device-relatedness, as well as serious or non-serious designation, is not captured in the registry.
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Cardiac disorders
Cardiac Arrest
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0.25%
3/1212 • Number of events 3 • Up to hospital discharge, approximately 24-48 hours
In the CathPCI registry data collection form, intra- and post-procedure adverse events are captured in a pre-specified list. Information on procedure and device-relatedness, as well as serious or non-serious designation, is not captured in the registry.
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Cardiac disorders
Cardiac Tamponade
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0.17%
2/1212 • Number of events 2 • Up to hospital discharge, approximately 24-48 hours
In the CathPCI registry data collection form, intra- and post-procedure adverse events are captured in a pre-specified list. Information on procedure and device-relatedness, as well as serious or non-serious designation, is not captured in the registry.
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Cardiac disorders
Cardiogenic Shock
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0.50%
6/1212 • Number of events 6 • Up to hospital discharge, approximately 24-48 hours
In the CathPCI registry data collection form, intra- and post-procedure adverse events are captured in a pre-specified list. Information on procedure and device-relatedness, as well as serious or non-serious designation, is not captured in the registry.
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Cardiac disorders
Heart Failure
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0.41%
5/1212 • Number of events 5 • Up to hospital discharge, approximately 24-48 hours
In the CathPCI registry data collection form, intra- and post-procedure adverse events are captured in a pre-specified list. Information on procedure and device-relatedness, as well as serious or non-serious designation, is not captured in the registry.
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Cardiac disorders
Myocardial Infarction
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0.66%
8/1212 • Number of events 8 • Up to hospital discharge, approximately 24-48 hours
In the CathPCI registry data collection form, intra- and post-procedure adverse events are captured in a pre-specified list. Information on procedure and device-relatedness, as well as serious or non-serious designation, is not captured in the registry.
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Renal and urinary disorders
New Requirement for Dialysis
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0.17%
2/1212 • Number of events 2 • Up to hospital discharge, approximately 24-48 hours
In the CathPCI registry data collection form, intra- and post-procedure adverse events are captured in a pre-specified list. Information on procedure and device-relatedness, as well as serious or non-serious designation, is not captured in the registry.
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Vascular disorders
Other Vascular Complications Requiring Treatment
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0.50%
6/1212 • Number of events 6 • Up to hospital discharge, approximately 24-48 hours
In the CathPCI registry data collection form, intra- and post-procedure adverse events are captured in a pre-specified list. Information on procedure and device-relatedness, as well as serious or non-serious designation, is not captured in the registry.
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Nervous system disorders
Stroke - Ischemic
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0.08%
1/1212 • Number of events 1 • Up to hospital discharge, approximately 24-48 hours
In the CathPCI registry data collection form, intra- and post-procedure adverse events are captured in a pre-specified list. Information on procedure and device-relatedness, as well as serious or non-serious designation, is not captured in the registry.
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place