Coronary Artery DiseaseNCT05021757
Disrupt CAD III Post-Approval Study (PAS)
An observational study of Coronary Artery Disease and Myocardial Infarction, run by Shockwave Medical, Inc. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction
- What is being tested?
- Shockwave C2 Coronary IVL
- Type of treatment
- Medical device
- How many people
- 1,212 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2021to 31 Mar 2022
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Subject is ≥18 years of age
- Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
- Left ventricular ejection fraction >25% within 6 months
- The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
- LAD, RCA or LCX (or of their branches) with:
- Stenosis of ≥70% and <100% or
Show all 10Show fewer
- 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
- The lesion length must not exceed 40 mm
- The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre-dilatation)
- Evidence of calcification at the lesion site by 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
Who cannot join
- Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure
- New York Heart Association (NYHA) class III or IV heart failure
- Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis
- Subjects in cardiogenic shock or with clinical evidence of acute heart failure
- Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
- Previous stent within target lesion (in-stent restenosis)
Trial locations and contacts
1 site in 1 country.
United States1 site
American College of Cardiology/National Cardiovascular Data Registry (NCDR)
Washington D.C., District of Columbia, 20037
About this study
Official title: New Enrollment Post Approval Registry for the Shockwave Intravascular Lithotripsy (IVL) System With Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
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.
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Being tested
- Shockwave C2 Coronary IVL
- Keywords
- Intravascular Lithotripsy, Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave C2 Coronary IVLDevice
PCI procedure using a Shockwave C2 coronary IVL catheter
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Shockwave C2 Coronary IVL |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Death Rate
Measured: Up to hospital discharge, approximately 24-48 hours
Number of Participants With Procedure-related Adverse Events
Measured: Up to hospital discharge, approximately 24-48 hours
Number of Participants With IVL-related Ventricular Arrhythmia
Measured: Up to hospital discharge, approximately 24-48 hours
Number of Participants With IVL Balloon Loss of Pressure/Rupture
Measured: Up to hospital discharge, approximately 24-48 hours
Number of Participants With Serious Coronary Dissection Following Balloon Loss of Pressure/Rupture
Measured: Up to hospital discharge, approximately 24-48 hours
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).
Measured: Up to hospital discharge, approximately 24-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start10 Mar 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,212 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Shockwave Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021757
- Sponsor's protocol ID
- CP 64647
- Status last verified
- Jan 2024
- First submitted
- 3 Aug 2021
- Last updated
- 1 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Enrollment Post Approval Registry for the Shockwave Intravascular Lithotripsy (IVL) System With Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
- ClinicalTrials.gov ID
- NCT05021757
- Acronym / sponsor ID
- CP 64647
- Conditions
- Coronary Artery Disease, Myocardial Infarction
- Keywords
- Intravascular Lithotripsy, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,212 participants (actual)
- Lead sponsor
- Shockwave Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Posted 1 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disrupt CAD III PAS Cohort | – | Device: Shockwave C2 Coronary IVLPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- Subject is ≥18 years of age
- Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
- Left ventricular ejection fraction >25% within 6 months
- The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
- LAD, RCA or LCX (or of their branches) with:
Key exclusion criteria (6 listed)
- Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure
- New York Heart Association (NYHA) class III or IV heart failure
- Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis
- Subjects in cardiogenic shock or with clinical evidence of acute heart failure
- Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shockwave C2 Coronary IVLPCI procedure using a Shockwave C2 coronary IVL catheter | Device | Disrupt CAD III PAS Cohort |
Primary outcome
All-cause Death Rate
Time frame: Up to hospital discharge, approximately 24-48 hours
Number of Participants With Procedure-related Adverse Events
Time frame: Up to hospital discharge, approximately 24-48 hours
Number of Participants With IVL-related Ventricular Arrhythmia
Time frame: Up to hospital discharge, approximately 24-48 hours
Number of Participants With IVL Balloon Loss of Pressure/Rupture
Time frame: Up to hospital discharge, approximately 24-48 hours
Number of Participants With Serious Coronary Dissection Following Balloon Loss of Pressure/Rupture
Time frame: Up to hospital discharge, approximately 24-48 hours
Number of IVL-related Pacing Issues in Patients With PPM/ICD
Time frame: Up to hospital discharge, approximately 24-48 hours
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Infarction, run by Shockwave Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause Death Rate (time frame: Up to hospital discharge, approximately 24-48 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.