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)
Part of paid clinical trials in Little Rock, Arkansas.
- Sponsor
- Shockwave Medical, Inc.
- Study ID
- NCT07062471
- Status
- Recruiting
Conditions
- Carotid Artery Calcification
- Carotid Artery Diseases
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Carotid Intravascular Lithotripsy (IVL) — DEVICEThe Shockwave Medical Intravascular Lithotripsy (IVL) System with the Shockwave SkyRunner Carotid IVL Catheter is intended for lithotripsy- enhanced balloon dilatation of ≥ 3 mm thick calcified lesions in the carotid arteries prior to stenting. Not for use for treating massive exophytic (mushroom-like) or irregular endoluminal carotid calcification, or in the coronary or cerebral arteries.
Study Details
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 Dates
- First listed
- Jul 14, 2025
- Start date
- Jun 22, 2026
- Status verified
- Jul 2026
- Primary completion
- Oct 31, 2027
- Completion
- Oct 31, 2032
Study Design
- Enrollment
- 185 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Calcified Carotid ArteryUp to 160 subjects for the primary analysis cohort, with 25 additional roll-in subjects, with calcified carotid arteries to be treated with intravascular lithotripsy (IVL) prior to stenting with commercially available trans-carotid stent systems in patients at high risk for complications from carotid endarterectomy (CEA) will be enrolled in the study.
Primary Outcome Measure
Composite endpoint with death, stroke, or myocardial infarction (MI) [Safety] [ Time Frame: 30 days ]
Central Contacts
- Danilo Romero+1-510-279-4262
- Birgit Greschner+1-510-279-4262
Locations (25)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | Scott Ryan (PRINCIPAL_INVESTIGATOR) |
| Eisenhower Medical Center | Rancho Mirage | California | 92270 | Trevor DerDerian (PRINCIPAL_INVESTIGATOR) |
| University of California Davis | Sacramento | California | 95817 | Misty Humphries (PRINCIPAL_INVESTIGATOR) |
| University of California San Diego | San Diego | California | 92037 | Mahmoud Malas (PRINCIPAL_INVESTIGATOR) |
| University of California San Francisco | San Francisco | California | 94121 | Peter Schneider (PRINCIPAL_INVESTIGATOR) |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | Kyle Reynolds (PRINCIPAL_INVESTIGATOR) |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | Michael Ayad (PRINCIPAL_INVESTIGATOR) |
| Advocate Health | Park Ridge | Illinois | 60068 | Atif Baqai (PRINCIPAL_INVESTIGATOR) |
| Tufts Medical Center | Boston | Massachusetts | 02111 | Shivani Kumar (PRINCIPAL_INVESTIGATOR) |
| McLaren Bay | Bay City | Michigan | 48708 | Nicolas Mouawad (PRINCIPAL_INVESTIGATOR) |
| Central Michigan University - Covenant Health | Saginaw | Michigan | 48604 | Ryan Kim (PRINCIPAL_INVESTIGATOR) |
| Allina Health Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | Jeffrey Jim (PRINCIPAL_INVESTIGATOR) |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | Jason Cook (PRINCIPAL_INVESTIGATOR) |
| University of Buffalo | Buffalo | New York | 14203 | Adnan Siddiqui (PRINCIPAL_INVESTIGATOR) |
| Mount Sinai Hospital | New York | New York | 10029 | Peter Faries (PRINCIPAL_INVESTIGATOR) |
| NYU Langone | New York | New York | 10016 | Thomas Maldonado (PRINCIPAL_INVESTIGATOR) |
| Weill Cornell Medicine - New York Presbyterian | New York | New York | 10065 | Brian DeRubertis (PRINCIPAL_INVESTIGATOR) |
| University of North Carolina Hospitals | Chapel Hill | North Carolina | 27514 | Daniel Calderon (PRINCIPAL_INVESTIGATOR) |
| Hatton Research Institution | Cincinnati | Ohio | 45242 | Patrick Muck (PRINCIPAL_INVESTIGATOR) |
| Providence Portland Medical Center | Portland | Oregon | 97213 | Brant Ullery (PRINCIPAL_INVESTIGATOR) |
| Main Line Health | Wynnewood | Pennsylvania | 19096 | Lynn Sher Robert Meisner (PRINCIPAL_INVESTIGATOR) |
| Sanford Health | Sioux Falls | South Dakota | 57105 | Anand Dayama (PRINCIPAL_INVESTIGATOR) |
| Baylor Scott & White Dallas | Dallas | Texas | 75226 | Javier Vasquez (PRINCIPAL_INVESTIGATOR) |
| Baylor Scott & White Plano | Plano | Texas | 75093 | Osniel Gonzalez Ramos Mazin Foteh (PRINCIPAL_INVESTIGATOR) |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | David Dexter (PRINCIPAL_INVESTIGATOR) |
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