Shockwaves to the neck: new device aims to make artery stenting safer

NCT ID NCT07512128

Not yet recruiting Disease control Sponsor: Shockwave Medical, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tests a device that uses sound waves (lithotripsy) to break up calcium buildup in the carotid arteries—the main arteries in the neck—before placing a stent to keep them open. The goal is to see if this approach reduces complications like stroke, heart attack, or death within 30 days. About 185 adults with calcified carotid arteries will be enrolled at multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Shockwave SkyRunner Carotid Intravascular Lithotripsy (IVL) Catheter
What this could lead to: If successful, this could provide a safer way to treat hardened neck arteries before placing a stent, potentially lowering the risk of stroke or heart attack during the procedure.
What could go wrong: This is an early-stage, single-arm study with no comparison group, so results may not prove the device is better than standard care. Risks include stroke, heart attack, or death from the procedure itself.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

calcinosis carotid artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CAROTID ARTERY CALCIFICATION CAROTID ARTERY DISEASES

Contacts and locations

Locations

Ascension Sacred Heart

Pensacola, Florida, 32504, United States
Ascension St. Vincent's

Jacksonville, Florida, 32204, United States
Baptist Health Research Institute

Jacksonville, Florida, 32207, United States
Baylor Scott & White Plano

Plano, Texas, 75093, United States
Cleveland Clinic

Cleveland, Ohio, 44195, United States
HCA HealthOne Swedish

Aurora, Colorado, 80012, United States
Houston Methodist

Houston, Texas, 77030, United States
Lexington Health

West Columbia, South Carolina, 29169, United States
Main Line Health System

Wynnewood, Pennsylvania, 19096, United States
Mercy South Hospital

St Louis, Missouri, 63128, United States
Mount Sinai

New York, New York, 10029, United States
NC Heart and Vascular

Raleigh, North Carolina, 27607, United States
North Central Heart, Avera Heart Hospital

Sioux Falls, South Dakota, 57108, United States
Pulse Institute

Scottsdale, Arizona, 85258, United States
St. Francis Hospital & Heart Center

Roslyn, New York, 11576, United States
Stern Cardiovascular Center

Germantown, Tennessee, 38138, United States
Tennova Healthcare

Knoxville, Tennessee, 37934, United States
The Miriam Hospital

Providence, Rhode Island, 02906, United States
UT MD Anderson Cancer Center

Houston, Texas, 77030, United States
University of Buffalo Neurosurgery

Buffalo, New York, 14203, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
WakeMed

Raleigh, North Carolina, 27610, United States
Wellmont Cardiology Services - CVA Heart Institute

Kingsport, Tennessee, 37660, United States
Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States
Willis-Knighton

Shreveport, Louisiana, 71103, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.