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)
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Shockwave Medical, Inc.
- Study ID
- NCT07512128
- Status
- Not Yet Recruiting
Notify me when recruiting opens
Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.
Add your contact details and location so we can keep your interest tied to this study.
Conditions
- Carotid Artery Calcification
- Carotid Artery Diseases
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Carotid Intravascular Lithotripsy — DEVICEThe Shockwave Medical Intravascular Lithotripsy (IVL) System with the Shockwave SkyRunner Carotid IVL Catheter is intended for lithotripsy- enhanced balloon dilatation of calcified lesions in the carotid arteries prior to stenting. Not for use 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-Femoral stenting (SKYWARD Trans-Femoral IDE Study)
Key Dates
- First listed
- Apr 6, 2026
- Start date
- Jul 31, 2026
- Status verified
- Jul 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 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-femoral stent systems in patients at high risk for complications from carotid endarterectomy (CEA) will be enrolled in the study.
Primary Outcome Measure
Primary Endpoint: Composite endpoint with death, stroke, or myocardial infarction (MI) [Safety] [ Time Frame: 30 days post procedure ]
Central Contacts
- Danilo Romero510-279-4262
- Birgit Greschner510-279-4262
Locations (25)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Pulse Institute | Scottsdale | Arizona | 85258 | Venkatesh Ramaiah (PRINCIPAL_INVESTIGATOR) |
| HCA HealthOne Swedish | Aurora | Colorado | 80012 | Ehrin Armstrong (PRINCIPAL_INVESTIGATOR) |
| Ascension St. Vincent's | Jacksonville | Florida | 32204 | Samer Garas (PRINCIPAL_INVESTIGATOR) |
| Baptist Health Research Institute | Jacksonville | Florida | 32207 | Ricardo Hanel (PRINCIPAL_INVESTIGATOR) |
| Ascension Sacred Heart | Pensacola | Florida | 32504 | Rohit Amin (PRINCIPAL_INVESTIGATOR) |
| Wellstar Kennestone Hospital | Marietta | Georgia | 30060 | Rishi Gupta (PRINCIPAL_INVESTIGATOR) |
| Willis-Knighton | Shreveport | Louisiana | 71103 | Ashish Sonig (PRINCIPAL_INVESTIGATOR) |
| Mercy South Hospital | St Louis | Missouri | 63128 | Anish Thomas (PRINCIPAL_INVESTIGATOR) |
| University of Buffalo Neurosurgery | Buffalo | New York | 14203 | Adnan Siddiqui (PRINCIPAL_INVESTIGATOR) |
| Mount Sinai | New York | New York | 10029 | Daryl Goldman (PRINCIPAL_INVESTIGATOR) |
| St. Francis Hospital & Heart Center | Roslyn | New York | 11576 | Lawrence Garcia (PRINCIPAL_INVESTIGATOR) |
| NC Heart and Vascular | Raleigh | North Carolina | 27607 | Ravish Sachar (PRINCIPAL_INVESTIGATOR) |
| WakeMed | Raleigh | North Carolina | 27610 | Siva Ketha (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Sean Lyden (PRINCIPAL_INVESTIGATOR) |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | Hakeem Shakir (PRINCIPAL_INVESTIGATOR) |
| Main Line Health System | Wynnewood | Pennsylvania | 19096 | Sarang Mangalmurti (PRINCIPAL_INVESTIGATOR) |
| The Miriam Hospital | Providence | Rhode Island | 02906 | Peter Soukas (PRINCIPAL_INVESTIGATOR) |
| Lexington Health | West Columbia | South Carolina | 29169 | Mathew Wooster (PRINCIPAL_INVESTIGATOR) |
| North Central Heart, Avera Heart Hospital | Sioux Falls | South Dakota | 57108 | Michael Bacharach (PRINCIPAL_INVESTIGATOR) |
| Stern Cardiovascular Center | Germantown | Tennessee | 38138 | James Klemis (PRINCIPAL_INVESTIGATOR) |
| Wellmont Cardiology Services - CVA Heart Institute | Kingsport | Tennessee | 37660 | Christopher Metzger (PRINCIPAL_INVESTIGATOR) |
| Tennova Healthcare | Knoxville | Tennessee | 37934 | - |
| Houston Methodist | Houston | Texas | 77030 | Alpesh Shah (PRINCIPAL_INVESTIGATOR) |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | Stephen Chen (PRINCIPAL_INVESTIGATOR) |
| Baylor Scott & White Plano | Plano | Texas | 75093 | Sameh Sayfo (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Scottsdale, AZ
Related Studies
- A Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization ApproachRecruiting · InspireMD · Sacramento, California
- 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 · Shockwave Medical, Inc. · Little Rock, Arkansas
- Intervascular Post-Market Clinical Follow-Up (PMCF) RegistryRecruiting · Intervascular · Hershey, Pennsylvania
- The CREST-2 RegistryRecruiting · University of Maryland, Baltimore · Baltimore, Maryland