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Not yet recruiting Not applicable Interventional

Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE [Investigational Device Exemption] Study)

ClinicalTrials.gov ID: NCT07512128

Public ClinicalTrials.gov record NCT07512128. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:15 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE Study)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral stenting (SKYWARD Trans-Femoral IDE Study)

Study identification

NCT ID
NCT07512128
Recruitment status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Shockwave Medical, Inc.
Industry
Enrollment
185 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2032
Last update posted
Jul 30, 2026

2026 – 2032

United States locations

U.S. sites
25
U.S. states
16
U.S. cities
22
Facility City State ZIP Site status
Pulse Institute Scottsdale Arizona 85258
HCA HealthOne Swedish Aurora Colorado 80012
Ascension St. Vincent's Jacksonville Florida 32204
Baptist Health Research Institute Jacksonville Florida 32207
Ascension Sacred Heart Pensacola Florida 32504
Wellstar Kennestone Hospital Marietta Georgia 30060
Willis-Knighton Shreveport Louisiana 71103
Mercy South Hospital St Louis Missouri 63128
University of Buffalo Neurosurgery Buffalo New York 14203
Mount Sinai New York New York 10029
St. Francis Hospital & Heart Center Roslyn New York 11576
NC Heart and Vascular Raleigh North Carolina 27607
WakeMed Raleigh North Carolina 27610
Cleveland Clinic Cleveland Ohio 44195
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104
Main Line Health System Wynnewood Pennsylvania 19096
The Miriam Hospital Providence Rhode Island 02906
Lexington Health West Columbia South Carolina 29169
North Central Heart, Avera Heart Hospital Sioux Falls South Dakota 57108
Stern Cardiovascular Center Germantown Tennessee 38138
Wellmont Cardiology Services - CVA Heart Institute Kingsport Tennessee 37660
Tennova Healthcare Knoxville Tennessee 37934
Houston Methodist Houston Texas 77030
UT MD Anderson Cancer Center Houston Texas 77030
Baylor Scott & White Plano Plano Texas 75093

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07512128, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 30, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07512128 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →