AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease

NCT07510438 | Recruiting DMC

• 1 other identifier: CL-00014
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 2

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.

Conditions

Coronary Arterial Disease (CAD)

Keywords

Intravascular Lithotripsy; IVL

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Pulse Intravascular Lithotripsy™ (Pulse IVL™)

EXPERIMENTAL

Pulse Intravascular Lithotripsy™ (Pulse IVL™) to open vessels with calcific walls

Device: Pulse Intravascular Lithotripsy (Pulse IVL)

Interventions

Pulse Intravascular Lithotripsy (Pulse IVL) DEVICE

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.

Pulse Intravascular Lithotripsy™ (Pulse IVL™)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amplitude Vascular Systems, Inc.: lead

Study Sites (2)

Monash Health, Victorian Heart Hospital

Melbourne, Victoria, 3168, Australia

RECRUITING

Auckland City Hospital

Auckland, 1142, New Zealand

RECRUITING

Central Study Contacts

Elizabeth Galle

CONTACT

651-324-4790; liz.galle@avspulse.com

Elise Gendreau

CONTACT

elise.gendreau@avspulse.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 3, 2026
• Study Start: May 8, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

NZ (1); AU (1)