NCT07510438 AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease
| NCT ID | NCT07510438 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Amplitude Vascular Systems, Inc. |
| Condition | Coronary Arterial Disease (CAD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-05-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2026-05-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Key Inclusion Criteria: * ≥ 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 Key Exclusion Criteria: * 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. * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07510438 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Arterial Disease (CAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07510438 currently recruiting?
Yes, NCT07510438 is actively recruiting participants. Contact the research team at liz.galle@avspulse.com for enrollment information.
Where is the NCT07510438 trial being conducted?
This trial is being conducted at Melbourne, Australia, Auckland, New Zealand.
Who is sponsoring the NCT07510438 clinical trial?
NCT07510438 is sponsored by Amplitude Vascular Systems, Inc.. The trial plans to enroll 15 participants.