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New treatment option for Coronary Arterial Disease (CAD)
Official title AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease
ClinicalTrials.gov ID: NCT07510438
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 18 years of age
- people 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...
You likely can't join if
- Subject experienced an acute Myocardial Infarction (MI), either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation...
- 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.
See the full eligibility criteria
- ≥ 18 years of age
- people 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...
- Lesion length must not exceed 44 mm Key
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
- Auckland, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia; Auckland, New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.