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)
Starting soon · Not applicable
Conditions studied: Carotid Artery Calcification, Carotid Artery Diseases
In brief
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)
Key facts
- Study ID
- NCT07512128
- Run by
- Shockwave Medical, Inc.
- People needed
- 185
- Starts
- 2026-07-01
- Expected to finish
- 2032-12-01
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Pulse Institute — Scottsdale, Arizona, United States
- HCA HealthOne Swedish — Aurora, Colorado, United States
- Ascension St. Vincent's — Jacksonville, Florida, United States
- Baptist Health Research Institute — Jacksonville, Florida, United States
- Ascension Sacred Heart — Pensacola, Florida, United States
- Wellstar Kennestone Hospital — Marietta, Georgia, United States
- Willis-Knighton — Shreveport, Louisiana, United States
- Mercy South Hospital — St Louis, Missouri, United States
- University of Buffalo Neurosurgery — Buffalo, New York, United States
- Mount Sinai — New York, New York, United States
- St. Francis Hospital & Heart Center — Roslyn, New York, United States
- NC Heart and Vascular — Raleigh, North Carolina, United States
- WakeMed — Raleigh, North Carolina, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
- Main Line Health System — Wynnewood, Pennsylvania, United States
- The Miriam Hospital — Providence, Rhode Island, United States
- Lexington Health — West Columbia, South Carolina, United States
- North Central Heart, Avera Heart Hospital — Sioux Falls, South Dakota, United States
- Stern Cardiovascular Center — Germantown, Tennessee, United States
- Wellmont Cardiology Services - CVA Heart Institute — Kingsport, Tennessee, United States
- Tennova Healthcare — Knoxville, Tennessee, United States
- Houston Methodist — Houston, Texas, United States
- UT MD Anderson Cancer Center — Houston, Texas, United States
- Baylor Scott & White Plano — Plano, Texas, United States
Full record on ClinicalTrials.gov
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