Coronary Arterial Disease (CAD)POWER CAD INCT07510438
AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease
A study testing Pulse Intravascular Lithotripsy (Pulse IVL) in people with Coronary Arterial Disease (CAD), run by Amplitude Vascular Systems, Inc. at 4 sites in 2 countries.
Trial summary
A prospective, open-label, multi-site, FIH with up to fifteen (n=15) patients to assess the safety and preliminary effectiveness of the AVS Pulse Intravascular Lithotripsy™ System (Pulse IVL™ System) when used for the treatment of coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD)
- What is being tested?
- Pulse Intravascular Lithotripsy (Pulse IVL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 8 May 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- ≥ 18 years of age
- Subjects with native coronary artery disease
- Left ventricular ejection fraction (LVEF) ≥ 35% within 6 months
- The target lesion must be a single de novo coronary lesion
- The target lesion stenosis of left anterior descending artery (LAD), right coronary artery (RCA), left circumflex artery (LCX), or ramus intermedius (RI), or of their branches with Stenosis of ≥70% and <100% or Stenosis ≥50% and <70% with evidence of ischemia
- Lesion length must not exceed 44 mm
Who cannot join
- Subject experienced an acute Myocardial Infarction (MI), either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) within 30 days prior to index procedure.
- Subject has New York Heart Association (NYHA) class III or IV heart failure.
- Subject has renal failure with serum creatinine >2.5 mg/dL, or chronic dialysis.
- Subject has a previous stent in the target vessel implanted within last six months.
- Unprotected LMCA diameter stenosis >30%.
- Target lesion has a myocardial bridge.
Show all 11Show fewer
- Target vessel is excessively tortuous, defined as the presence of 2 or more bends >90 degrees or 3 or more bends >75 degrees.
- Evidence of aneurysm in target vessel within 10 mm of the target lesion.
- Target lesion in ostial location (LAD, RCA, LCX, or RI, within 5 mm of ostium) or in an unprotected LMCA.
- Target lesion is a bifurcation with ostial diameter stenosis ≥30%.
- Any previous stent within 10 mm of the target lesion.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Elise Gendreau contact
4 sites in 2 countries
Australia3 sites, 3 recruiting
- Recruiting
St. Vincent's Hospital
Melbourne, Victoria, 3065
Robert Whitbourn, MD
- Recruiting
Monash Health, Victorian Heart Hospital
Melbourne, Victoria, 3168
Robert Gooley, MD
- Recruiting
St. Vincent's Hospital
Sydney, New South Wales, 2010
David Muller, MD
New Zealand1 site, 1 recruiting
- Recruiting
Auckland City Hospital
Auckland, 1142
Jithendra Somaratne, MD
About this study
Official title: AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease - A First-in-Human (FIH) Study
A prospective, open-label, multi-site, FIH with up to fifteen (n=15) patients to assess the safety and preliminary effectiveness of the AVS Pulse Intravascular Lithotripsy™ System (Pulse IVL™ System) when used for the treatment of coronary artery disease.
- Conditions
- Coronary Arterial Disease (CAD)
- Being tested
- Pulse Intravascular Lithotripsy (Pulse IVL)
- Keywords
- Intravascular Lithotripsy, IVL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse Intravascular Lithotripsy (Pulse IVL)Device
The Pulse Intravascular Lithotripsy (Pulse IVL) System is used for the treatment of severely calcified stenotic de novo coronary arteries prior to stenting in patients with coronary artery disease.
| Study group | Role | What they receive |
|---|---|---|
| Pulse Intravascular Lithotripsy™ (Pulse IVL™) | Experimental | Pulse Intravascular Lithotripsy™ (Pulse IVL™) to open vessels with calcific walls Receives: Device: Pulse Intravascular Lithotripsy (Pulse IVL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieve residual stenosis (<50%) in conjunction with stenting in the absence of major device related adverse events
Measured: Completion of study procedure
Target lesion failure (TLF)
Measured: Within 30 days of study procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start8 May 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amplitude Vascular Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510438
- Sponsor's protocol ID
- CL-00014
- Acronym
- POWER CAD I
- Status last verified
- Oct 2026
- First submitted
- 30 Mar 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease - A First-in-Human (FIH) Study
- ClinicalTrials.gov ID
- NCT07510438
- Acronym / sponsor ID
- POWER CAD I / CL-00014
- Conditions
- Coronary Arterial Disease (CAD)
- Keywords
- Intravascular Lithotripsy, IVL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Amplitude Vascular Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, open-label, multi-site, FIH with up to fifteen (n=15) patients to assess the safety and preliminary effectiveness of the AVS Pulse Intravascular Lithotripsy™ System (Pulse IVL™ System) when used for the treatment of coronary artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulse Intravascular Lithotripsy™ (Pulse IVL™) | Experimental | Device: Pulse Intravascular Lithotripsy (Pulse IVL)Pulse Intravascular Lithotripsy™ (Pulse IVL™) to open vessels with calcific walls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years of age
- Subjects with native coronary artery disease
- Left ventricular ejection fraction (LVEF) ≥ 35% within 6 months
- The target lesion must be a single de novo coronary lesion
- The target lesion stenosis of left anterior descending artery (LAD), right coronary artery (RCA), left circumflex artery (LCX), or ramus intermedius (RI), or of their branches with Stenosis of ≥70% and <100% or Stenosis ≥50% and <70% with evidence of ischemia
Key exclusion criteria (11 listed)
- Subject experienced an acute Myocardial Infarction (MI), either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) within 30 days prior to index procedure.
- Subject has New York Heart Association (NYHA) class III or IV heart failure.
- Subject has renal failure with serum creatinine >2.5 mg/dL, or chronic dialysis.
- Subject has a previous stent in the target vessel implanted within last six months.
- Unprotected LMCA diameter stenosis >30%.
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 |
|---|---|---|
| Pulse Intravascular Lithotripsy (Pulse IVL)The Pulse Intravascular Lithotripsy (Pulse IVL) System is used for the treatment of severely calcified stenotic de novo coronary arteries prior to stenting in patients with coronary artery disease. | Device | Pulse Intravascular Lithotripsy™ (Pulse IVL™) |
Primary outcome
Achieve residual stenosis (<50%) in conjunction with stenting in the absence of major device related adverse events
Time frame: Completion of study procedure
Target lesion failure (TLF)
Time frame: Within 30 days of study procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
Elise Gendreau contact
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse Intravascular Lithotripsy (Pulse IVL) in people with Coronary Arterial Disease (CAD), run by Amplitude Vascular Systems, Inc. at 4 sites in 2 countries.
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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, New Zealand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Galle (651-324-4790, liz.galle@avspulse.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieve residual stenosis (<50%) in conjunction with stenting in the absence of major device related adverse events (time frame: Completion of study procedure). The study lists 2 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 2 Nov 2026.