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

NCT05828173 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-06

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Elixir Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Stefan Verheye, MD, PhD · ZNA Middelheim, Antwerp, Belgium

  • Johan Bennett, MD, PhD · Universitaire Ziekenhuizen Leuven, Leuven, Belgium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-27
Primary Completion
2024-03-29
Completion
2024-09-09

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05828173 on ClinicalTrials.gov