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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• ≥ 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
Locations
Other Locations
Australia
Monash Health, Victorian Heart Hospital
RECRUITING
Melbourne
New Zealand
Auckland City Hospital
RECRUITING
Auckland
Contact Information
Primary
Elizabeth Galle
liz.galle@avspulse.com
651-324-4790
Backup
Elise Gendreau
elise.gendreau@avspulse.com
Time Frame
Start Date: 2026-05-08
Estimated Completion Date: 2027-12
Participants
Target number of participants: 15
Treatments
Experimental: Pulse Intravascular Lithotripsy™ (Pulse IVL™)
Pulse Intravascular Lithotripsy™ (Pulse IVL™) to open vessels with calcific walls
Related Therapeutic Areas
Sponsors
Leads: Amplitude Vascular Systems, Inc.