Actively Recruiting
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 Study
Led by Amplitude Vascular Systems, Inc. · Updated on 2026-05-18
15
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and early effectiveness of the AVS Pulse Intravascular Lithotripsy (Pulse IVL) System for treating coronary artery disease. This first-in-human, open-label study will include up to fifteen patients with severely calcified coronary arteries. The study aims to assess how well the device opens vessels with calcific walls and enhances vascular compliance and remodeling. Participants will receive treatment using the Pulse IVL System to prepare severely calcified coronary arteries before stenting. The study focuses on treating single new coronary lesions in arteries such as the left anterior descending, right coronary, left circumflex, or ramus intermedius. The treatment involves using the device to break down calcifications to allow stent placement. This study has no placebo or comparator group, and all participants receive the investigational device. During the study, participants will be closely monitored for residual narrowing of the artery after treatment and stenting, aiming for less than 50% stenosis. Researchers will also track any major device-related adverse events and target lesion failure within 30 days of the procedure. Participants will undergo assessments including imaging and clinical evaluations to measure safety and effectiveness. The study is expected to continue through December 2027, with detailed follow-up after the procedure.
CONDITIONS
Brief Title
AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosis of native coronary artery disease
- Left ventricular ejection fraction (LVEF) of 35% or higher within the last 6 months
- Single de novo coronary artery lesion
- Target lesion stenosis of 70% or more and less than 100%, or stenosis 50% or more and less than 70% with evidence of ischemia
- Lesion length not exceeding 44 mm
You will not qualify if you...
- Acute myocardial infarction (STEMI or NSTEMI) within 30 days prior to procedure
- New York Heart Association (NYHA) class III or IV heart failure
- Renal failure with serum creatinine greater than 2.5 mg/dL or on chronic dialysis
- Previous stent in the target vessel within last 6 months
- Unprotected left main coronary artery (LMCA) diameter stenosis greater than 30%
- Target lesion with myocardial bridge
- Target vessel excessively tortuous with 2 or more bends over 90 degrees or 3 or more bends over 75 degrees
- Evidence of aneurysm near the target lesion
- Target lesion in ostial location or unprotected LMCA
- Target lesion is a bifurcation with ostial diameter stenosis 30% or more
- Any previous stent within 10 mm of target lesion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure day
Participants undergo the Pulse Intravascular Lithotripsy (Pulse IVL) procedure to open vessels with calcific walls prior to stenting for coronary artery disease.
1 in-person procedure visit
Trial Site Locations
Total: 2 locations
1
Monash Health, Victorian Heart Hospital
Melbourne, Victoria, Australia, 3168
Actively Recruiting
2
Auckland City Hospital
Auckland, New Zealand, 1142
Actively Recruiting
Research Team
E
Elizabeth Galle
E
Elise Gendreau
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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