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)
SKYWARD TF
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)
1 other identifier
interventional
185
1 country
25
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Longer than P75 for not_applicable
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2026
CompletedFirst Posted
Study publicly available on registry
April 6, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2032
July 31, 2026
July 1, 2026
1.4 years
March 30, 2026
July 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Endpoint: Composite endpoint with death, stroke, or myocardial infarction (MI) [Safety]
A composite endpoint with death, stroke (disabling or non-disabling based on NeuroARC definitions) or myocardial infarction (MI) (using the SCAI definition for peri-procedural MI and the 4th Universal Definition for spontaneous MI beyond 48 hours) at 30 days post procedure.
30 days post procedure
Secondary Outcomes (12)
Incidence of any stroke
30 days, 6, 12, 24, 36, 48 and 60 months post procedure
Proportion of subjects with Device Success without serious angiographic complications
Day 0
Proportion of subjects with residual diameter stenosis ≤ 50%
Day 0
Proportion of subjects with a residual stenosis of ≤ 30%
Day 0
Incidence of Myocardial Infarction (MI)
Day 0, 30 days, 6, 12, 24, 36, 48 and 60 months post procedure
- +7 more secondary outcomes
Study Arms (1)
Calcified Carotid Artery
EXPERIMENTALUp 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.
Interventions
The 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.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years.
- Patient is able and willing to comply with all assessments in the study.
- Patient has been informed of the nature of the study, agrees to participate and has signed the approved informed consent form.
- Patient must have a life expectancy \> 1 year at the time of the index procedure, in the opinion of the investigator at the time of enrollment, with no planned major cardiac intervention or surgery within 30 days following the index procedure.
- Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the carotid bifurcation.
- Target lesion must meet all requirements for commercially available trans-femoral stent systems (refer to IFU for requirements) and investigator intends to treat the target lesion with a single stent.
- Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis by duplex ultrasound in combination with CT or MR angiography:
- Symptomatic: ≥ 50% stenosis of the internal carotid artery and the patient has a history of stroke, TIA and/or amaurosis fugax within 180 days of the procedure ipsilateral to the carotid artery to be treated.
- Asymptomatic: ≥ 70% stenosis of the internal carotid artery without any neurological symptoms.
- Patient has evidence of circumferential calcification of the stenotic lesion defined as ≥ 3 mm thickness of calcification as determined by Computed Tomography Angiography (CTA). MR angiography may be used in place of CTA for patients with a relative or absolute contraindication to CTA.
- Patient is high risk for CEA defined as meeting at least one anatomic or clinical high-risk condition listed below:
- Target lesion at or above C2 (level of jaw) or below the clavicle
- Inability to extend the head due to cervical arthritis or other cervical disorders
- History of radiation treatment to the neck or radical neck dissection
- Prior head and neck surgery in the region of the carotid artery
- +17 more criteria
You may not qualify if:
- Patient has alternative source of cerebral embolus, including but not limited to:
- a history of chronic atrial flutter or atrial fibrillation, or paroxysmal atrial flutter or atrial fibrillation requiring chronic anticoagulation
- knowledge of cardiac sources of emboli (e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, hemodynamically significant aortic stenosis, endocarditis, mitral stenosis, or left atrial myxoma)
- recently (\< 60 days) replaced/repaired heart valve (either surgically or percutaneously).
- Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, a hemorrhagic transformation of an ischemic stroke within the past 60 days or has had a recent stroke (\< 7 days) of sufficient size (on CT or MRI) to place the patient at risk of hemorrhagic conversion during the procedure.
- Patient with a history of major stroke with substantial neurological deficit (NIHSS ≥ 5 or mRS ≥ 3) within 1 month of index procedure.
- Patient has had a TIA, or amaurosis fugax within 48 hours prior to the procedure.
- Patient has neurologic illnesses within the past 2 years characterized by fleeting or fixed neurologic or cognitive deficit which cannot be distinguished from TIA or stroke.
- Patient has an intracranial tumor.
- Patient has an unresolved/uncorrected bleeding disorder.
- Patient had a myocardial infarction (MI) within last 72 hours prior to index procedure.
- Patient has history of intolerance or allergic reaction to contrast material that cannot be adequately premedicated or to any of the required study medications (i.e., antiplatelet agents, statins) or device materials (refer to IFUs).
- Female patients who are pregnant, nursing, or may become pregnant.
- Patient is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached its primary endpoint.
- Patient has other medical, social, or psychological problems that, in the opinion of the investigator, would present difficulty in complying with protocol requirements.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shockwave Medical, Inc.lead
- Medpace, Inc.collaborator
- Yale Cardiovascular Research Groupcollaborator
- Cardiovascular Research Foundation, New Yorkcollaborator
- Massachusetts General Hospitalcollaborator
Study Sites (25)
Pulse Institute
Scottsdale, Arizona, 85258, United States
HCA HealthOne Swedish
Aurora, Colorado, 80012, United States
Ascension St. Vincent's
Jacksonville, Florida, 32204, United States
Baptist Health Research Institute
Jacksonville, Florida, 32207, United States
Ascension Sacred Heart
Pensacola, Florida, 32504, United States
Wellstar Kennestone Hospital
Marietta, Georgia, 30060, United States
Willis-Knighton
Shreveport, Louisiana, 71103, United States
Mercy South Hospital
St Louis, Missouri, 63128, United States
University of Buffalo Neurosurgery
Buffalo, New York, 14203, United States
Mount Sinai
New York, New York, 10029, United States
St. Francis Hospital & Heart Center
Roslyn, New York, 11576, United States
NC Heart and Vascular
Raleigh, North Carolina, 27607, United States
WakeMed
Raleigh, North Carolina, 27610, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Main Line Health System
Wynnewood, Pennsylvania, 19096, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Lexington Health
West Columbia, South Carolina, 29169, United States
North Central Heart, Avera Heart Hospital
Sioux Falls, South Dakota, 57108, United States
Stern Cardiovascular Center
Germantown, Tennessee, 38138, United States
Wellmont Cardiology Services - CVA Heart Institute
Kingsport, Tennessee, 37660, United States
Tennova Healthcare
Knoxville, Tennessee, 37934, United States
Houston Methodist
Houston, Texas, 77030, United States
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Baylor Scott & White Plano
Plano, Texas, 75093, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2026
First Posted
April 6, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2032
Last Updated
July 31, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share