Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid IDE [Investigational Device Exemption] Study)
Recruiting now · 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-Carotid Stenting (SKYWARD Trans-Carotid IDE Study)
Key facts
- Study ID
- NCT07062471
- Run by
- Shockwave Medical, Inc.
- People needed
- 185
- Starts
- 2026-06-22
- Expected to finish
- 2032-10-01
- 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
- Mount Sinai Hospital — New York, New York, United States (enrolling)
- Advocate Health — Park Ridge, Illinois, United States (enrolling)
- Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
- Hatton Research Institution — Cincinnati, Ohio, United States (enrolling)
- McLaren Bay — Bay City, Michigan, United States (enrolling)
- Central Michigan University - Covenant Health — Saginaw, Michigan, United States (enrolling)
- Allina Health Minneapolis Heart Institute — Minneapolis, Minnesota, United States (enrolling)
- Eisenhower Medical Center — Rancho Mirage, California, United States (enrolling)
- University of Buffalo — Buffalo, New York, United States (enrolling)
- University of California San Francisco — San Francisco, California, United States (enrolling)
- Main Line Health — Wynnewood, Pennsylvania, United States
- Sanford Health — Sioux Falls, South Dakota, United States
- Baylor Scott & White Dallas — Dallas, Texas, United States
- Baylor Scott & White Plano — Plano, Texas, United States
- Arkansas Heart Hospital — Little Rock, Arkansas, United States
- Sentara Norfolk General Hospital — Norfolk, Virginia, United States
- University of California Davis — Sacramento, California, United States
- University of California San Diego — San Diego, California, United States
- Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
- Mount Sinai Medical Center — Miami Beach, Florida, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- NYU Langone — New York, New York, United States
- Weill Cornell Medicine - New York Presbyterian — New York, New York, United States
- University of North Carolina Hospitals — Chapel Hill, North Carolina, United States
- Providence Portland Medical Center — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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