Coronary Arterial Disease (CAD)
Conditions
Keywords
Intravascular Lithotripsy, IVL
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.
Interventions
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.
Sponsors
Amplitude Vascular Systems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achieve residual stenosis (<50%) in conjunction with stenting in the absence of major device related adverse events | Completion of study procedure |
| Target lesion failure (TLF) | Within 30 days of study procedure |
Countries
Australia, New Zealand
Contacts
CONTACTElizabeth Galle
CONTACTElise Gendreau
Outcome results
None listed