AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulse Intravascular Lithotripsy (Pulse IVL).
- Who it may be relevant to
- Registry conditions: Coronary Arterial Disease (CAD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, New Zealand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- 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]
Eligibility criteria
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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- Monash Health, Victorian Heart Hospital — Melbourne
New Zealand · 1 center
- Auckland City Hospital — Auckland
Identifiers
NCT: NCT07510438 · CL-00014