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CompletedNCT05021757Updated Feb 1, 2024Results posted

Disrupt CAD III Post-Approval Study (PAS)

An observational study in Coronary Artery Disease and Myocardial Infarction, sponsored by Shockwave Medical, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-01.

Sponsored by Shockwave Medical, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,212
Ages
18 Years and older
Sex
All
01

Study summary

The study design is a prospective, multicenter, observational, single-arm post-approval study using data collected in the National Cardiovascular Data Registry (NCDR®) CathPCI Registry®.

Read the detailed description

Subject Population: Patients ≥18 years of age with severely calcified, stenotic de novo coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI) and with clinical characteristics similar to the Disrupt CAD III IDE study. Approximately 1000 patients in the CathPCI Registry® (including a minimum of 30 patients with permanent pacemakers [PPM] or implantable cardioverter defibrillators [ICDs]) will be enrolled. Subjects will be followed through discharge.

02

Conditions studied

  • Coronary Artery Disease
  • Myocardial Infarction

Keywords

  • Intravascular Lithotripsy
  • Percutaneous Coronary Intervention
03

In context

Coronary Artery Disease

5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's enrollment of 1,212 is above the median of 336 across 1,946 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Shockwave Medical, Inc. is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with severely calcified, stenotic de novo coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI) and with clinical characteristics similar to the Disrupt CAD III IDE study.

Inclusion criteria

  1. Subject is ≥18 years of age
  2. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
  3. Left ventricular ejection fraction >25% within 6 months
  4. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure

  5. LAD, RCA or LCX (or of their branches) with:

    • Stenosis of ≥70% and \<100% or
    • Stenosis ≥50% and \<99% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve (FFR) value ≤0.80, or iFR \<0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²
  6. The lesion length must not exceed 40 mm
  7. The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre-dilatation)
  8. Evidence of calcification at the lesion site by angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location

Exclusion criteria

Exclusion Criteria:

  1. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure
  2. New York Heart Association (NYHA) class III or IV heart failure
  3. Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis
  4. Subjects in cardiogenic shock or with clinical evidence of acute heart failure
  5. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
  6. Previous stent within target lesion (in-stent restenosis)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,212 participants (actual)
Target follow-up
2 Days
Patient registry
Yes

Groups and cohorts

  • 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.

    Device: Shockwave C2 Coronary IVL

Interventions

  • DeviceShockwave C2 Coronary IVL

    PCI procedure using a Shockwave C2 coronary IVL catheter

06

What researchers measure

Primary outcomes

  1. All-cause Death Rate

    Time frame: Up to hospital discharge, approximately 24-48 hours

  2. Number of Participants With Procedure-related Adverse Events

    Time frame: Up to hospital discharge, approximately 24-48 hours

  3. Number of Participants With IVL-related Ventricular Arrhythmia

    Time frame: Up to hospital discharge, approximately 24-48 hours

  4. Number of Participants With IVL Balloon Loss of Pressure/Rupture

    Time frame: Up to hospital discharge, approximately 24-48 hours

  5. Number of Participants With Serious Coronary Dissection Following Balloon Loss of Pressure/Rupture

    Time frame: Up to hospital discharge, approximately 24-48 hours

  6. Number of IVL-related Pacing Issues in Patients With PPM/ICD

    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).

    Time frame: Up to hospital discharge, approximately 24-48 hours

07

Results

Posted Feb 1, 2024

Participant flow

Participant flow — Overall Study
MilestoneDisrupt CAD III PAS Cohort
Started1212
Completed1212
Not completed0

Outcome measures

PrimaryAll-cause Death Rate
Time frame:
Up to hospital discharge, approximately 24-48 hours
Reported as:
Count of participants · Participants
All-cause Death Rate
ParticipantsDisrupt CAD III PAS Cohort
All-cause Death Rate3
PrimaryNumber of Participants With Procedure-related Adverse Events
Time frame:
Up to hospital discharge, approximately 24-48 hours
Reported as:
Count of participants · Participants
Number of Participants With Procedure-related Adverse Events
ParticipantsDisrupt CAD III PAS Cohort
Number of Participants With Procedure-related Adverse Events35
PrimaryNumber of Participants With IVL-related Ventricular Arrhythmia
Time frame:
Up to hospital discharge, approximately 24-48 hours
Reported as:
Count of participants · Participants
Number of Participants With IVL-related Ventricular Arrhythmia
ParticipantsDisrupt CAD III PAS Cohort
Number of Participants With IVL-related Ventricular Arrhythmia0
PrimaryNumber of Participants With IVL Balloon Loss of Pressure/Rupture
Time frame:
Up to hospital discharge, approximately 24-48 hours
Reported as:
Count of participants · Participants
Number of Participants With IVL Balloon Loss of Pressure/Rupture
ParticipantsDisrupt CAD III PAS Cohort
Number of Participants With IVL Balloon Loss of Pressure/Rupture2
PrimaryNumber of Participants With Serious Coronary Dissection Following Balloon Loss of Pressure/Rupture
Time frame:
Up to hospital discharge, approximately 24-48 hours
Reported as:
Count of participants · Participants
Number of Participants With Serious Coronary Dissection Following Balloon Loss of Pressure/Rupture
ParticipantsDisrupt CAD III PAS Cohort
Number of Participants With Serious Coronary Dissection Following Balloon Loss of Pressure/Rupture0
PrimaryNumber of IVL-related Pacing Issues in Patients With PPM/ICD

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).

Time frame:
Up to hospital discharge, approximately 24-48 hours
Reported as:
Count of participants · Participants
Number of IVL-related Pacing Issues in Patients With PPM/ICD
ParticipantsDisrupt CAD III PAS Cohort
Number of IVL-related Pacing Issues in Patients With PPM/ICD0

Adverse events

Collected over Up to hospital discharge, approximately 24-48 hours. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Disrupt CAD III PAS Cohort3/1,212 (0.2%)35/1,212 (2.9%)0/1,212 (0%)
Most frequent serious events
Showing 10 of 15
Most frequent serious events
EventDisrupt CAD III PAS Cohort
Myocardial InfarctionCardiac disorders8/1212
Coronary Artery PerforationCardiac disorders7/1212
Cardiogenic ShockCardiac disorders6/1212
Other Vascular Complications Requiring TreatmentVascular disorders6/1212
Significant Coronary Artery Dissection (C and above)Cardiac disorders5/1212
Heart FailureCardiac disorders5/1212
Bleeding - Hematoma at Access SiteInjury, poisoning and procedural complications3/1212
Cardiac ArrestCardiac disorders3/1212
Bleeding - Access SiteInjury, poisoning and procedural complications2/1212
Bleeding - RetroperitonealInjury, poisoning and procedural complications2/1212

Baseline characteristics

Age, Continuous
Age, Continuous(years)Disrupt CAD III PAS Cohort
Mean73.4 ± 9.0
Sex: Female, Male
Sex: Female, Male(Participants)Disrupt CAD III PAS Cohort
Female330
Male882
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Disrupt CAD III PAS Cohort
American Indian or Alaska Native2
Asian36
Native Hawaiian or Other Pacific Islander2
Black or African American68
White1060
More than one race2
Unknown or Not Reported42
Region of Enrollment
Region of Enrollment(participants)Disrupt CAD III PAS Cohort
United States1212
08

Study locations

1 site
  • American College of Cardiology/National Cardiovascular Data Registry (NCDR)
    Washington, District of Columbia 20037, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 4, 2021

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05021757
Lead sponsor
Shockwave Medical, Inc.
Responsible party
Sponsor
First posted
Aug 25, 2021
Start date
Mar 10, 2021
Primary completion
Mar 31, 2022
Completion
Mar 31, 2022
Results posted
Feb 1, 2024
Last update
Feb 1, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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