NCT05828173

A Clinical Trial to Assess the Elixir Medical LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter

PINNACLE I Clinical Study: a Clinical Trial to Assess the Elixir Medical LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter for Treatment of Moderately to Severely Calcified, Stenotic De Novo Coronary Artery Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Elixir Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the PINNACLE I Clinical Study is to assess safety and performance of the LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX) to treat moderately to severely calcified coronary artery lesions by calcium fragmentation utilizing Hertzian contact stress from LithiX HCIVLC.

Detailed description

This study is a prospective, multicenter, single-arm clinical study. Enrollment of up to 60 patients requiring percutaneous coronary intervention (PCI) on up to two de novo coronary artery lesions with reference vessel diameters ≥ 2.25 mm and ≤ 3.5 mm, and lesion lengths of ≤ 34 mm, with moderate to severe calcification. The LithiX Coronary HCIVLC is a proprietary Hertzian contact intravascular lithotripsy catheter delivered through the coronary arterial system to visualize and treat calcified stenoses potentially resistant to full stent expansion. The LithiX Coronary HCIVLC consists of a semi-compliant balloon featuring multiple rows of stainless-steel hemispheres which are intended to atraumatically fragment calcium via Hertzian contact intravascular lithotripsy. In the Optical Coherence Tomography (OCT) imaging subgroup, approximately 30 patients will undergo OCT imaging at pre-procedure, post-LithiX treatment, and the end of procedure following stent deployment. Subjects will be followed through hospital discharge and will have clinical follow-up conducted by phone at 30 days and 6 months post-index procedure.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX)	Vessel preparation of moderately to severely calcified coronary artery lesions prior to stenting allows for full stent expansion and apposition to the vessel wall

Timeline

• Start date: 2023-04-27
• Primary completion: 2024-03-29
• Completion: 2024-09-09
• First posted: 2023-04-25
• Last updated: 2025-03-06

Locations

7 sites across 2 countries: Belgium, Netherlands