Sound waves to zap artery calcium before stenting: new trial launches

NCT ID NCT07062471

Recruiting now Disease control Sponsor: Shockwave Medical, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tests a new device that uses sound waves (lithotripsy) to break up hard calcium deposits in the carotid arteries of the neck before placing a stent. About 185 people with heavily calcified carotid arteries will be enrolled. The main goal is to see if the procedure is safe, measuring rates of death, stroke, or heart attack within 30 days.

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 (a device that uses sound waves to break up calcium in arteries)
What this could lead to: If successful, this device could make carotid stenting safer and more effective for people with heavily calcified neck arteries, reducing the risk of stroke or death 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 existing treatments. Risks include stroke, heart attack, or death from the procedure.

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

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Conditions

The condition(s) this trial relates to.

calcinosis carotid artery disorder carotid stenosis

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

Advocate Health
RECRUITING

Park Ridge, Illinois, 60068, United States
Allina Health Minneapolis Heart Institute
RECRUITING

Minneapolis, Minnesota, 55407, United States
Arkansas Heart Hospital
NOT_YET_RECRUITING

Little Rock, Arkansas, 72211, United States
Baylor Scott & White Dallas
NOT_YET_RECRUITING

Dallas, Texas, 75226, United States
Baylor Scott & White Plano
NOT_YET_RECRUITING

Plano, Texas, 75093, United States
Central Michigan University - Covenant Health
RECRUITING

Saginaw, Michigan, 48604, United States
Eisenhower Medical Center
RECRUITING

Rancho Mirage, California, 92270, United States
Hatton Research Institution
RECRUITING

Cincinnati, Ohio, 45242, United States
Main Line Health
NOT_YET_RECRUITING

Wynnewood, Pennsylvania, 19096, United States
McLaren Bay
RECRUITING

Bay City, Michigan, 48708, United States
Medstar Washington Hospital Center
NOT_YET_RECRUITING

Washington D.C., District of Columbia, 20010, United States
Mount Sinai Hospital
RECRUITING

New York, New York, 10029, United States
Mount Sinai Medical Center
NOT_YET_RECRUITING

Miami Beach, Florida, 33140, United States
NYU Langone
NOT_YET_RECRUITING

New York, New York, 10016, United States
Providence Portland Medical Center
NOT_YET_RECRUITING

Portland, Oregon, 97213, United States
Sanford Health
NOT_YET_RECRUITING

Sioux Falls, South Dakota, 57105, United States
Sentara Norfolk General Hospital
NOT_YET_RECRUITING

Norfolk, Virginia, 23507, United States
Tufts Medical Center
RECRUITING

Boston, Massachusetts, 02111, United States
University of Buffalo
RECRUITING

Buffalo, New York, 14203, United States
University of California Davis
NOT_YET_RECRUITING

Sacramento, California, 95817, United States
University of California San Diego
NOT_YET_RECRUITING

San Diego, California, 92037, United States
University of California San Francisco
RECRUITING

San Francisco, California, 94121, United States
University of Nebraska Medical Center
NOT_YET_RECRUITING

Omaha, Nebraska, 68198, United States
University of North Carolina Hospitals
NOT_YET_RECRUITING

Chapel Hill, North Carolina, 27514, United States
Weill Cornell Medicine - New York Presbyterian
NOT_YET_RECRUITING

New York, New York, 10065, United States

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