Pulse IVL to open calcified coronary vessels in CAD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, multi-site feasibility study enrolling up to 15 adults with native CAD. The study uses the Pulse IVL system to treat a single de novo coronary lesion with significant narrowing. Participants must have adequate heart function and no recent major heart attack, with lesion length limited to 44 mm. Safety and preliminary effectiveness are the primary focus. No control group is described, and the trial is conducted at several Australian centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• St. Vincent's Hospital
  Sydney, New South Wales, Australia Recruiting
• St. Vincent's Hospital
  Melbourne, Victoria, Australia Recruiting
• Monash Health, Victorian Heart Hospital
  Melbourne, Victoria, Australia Recruiting
• Auckland City Hospital
  Auckland, New Zealand Recruiting

Study contacts

• Study coordinator: Elizabeth Galle
• Email: liz.galle@avspulse.com
• Phone: 651-324-4790

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.