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)

NCT07062471 | Recruiting DMC FDA Device

• 1 other identifier: CP 75489
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 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-Carotid Stenting (SKYWARD Trans-Carotid IDE Study)

Conditions

Carotid Artery Calcification; Carotid Artery Diseases

Keywords

IVL; Carotid Calcification; Calcification

Outcome Measures

Primary Outcomes (1)

• Composite endpoint with death, stroke, or myocardial infarction (MI) [Safety]

  A composite endpoint with death, stroke (disabling or non-disabling based on NeuroARC \[Neurologic Academic Research Consortium\] definitions) or myocardial infarction (MI) (using the SCAI \[Society for Cardiovascular Angiography \& Intervention\] definition for peri- procedural MI and the 4th Universal Definition for spontaneous MI beyond 48 hours) at 30 days post procedure.

  30 days

Secondary Outcomes (12)

• Incidence of any stroke

  30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months

• 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.

Study Arms (1)

Calcified Carotid Artery

EXPERIMENTAL

Up 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.

Device: Carotid Intravascular Lithotripsy (IVL)

Interventions

Carotid Intravascular Lithotripsy (IVL) DEVICE

The 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.

Also known as: Intravascular Lithotripsy (IVL)

Calcified Carotid Artery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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-carotid 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:
• Contralateral Carotid artery occlusion.
• Tandem Stenoses \> 70%.
• High cervical carotid artery stenosis.
• Restenosis after carotid endarterectomy.

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 isolated hemisphere.
• Patient has an open stoma in the neck.
• Patient has an unresolved/uncorrected bleeding disorder.
• Patient had a myocardial infarction (MI) within last 72 hours prior to index procedure.
• Patient has contralateral laryngeal, lateral recurrent, or vagus nerve injury.
• 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).

Sponsors & Collaborators

• Yale Cardiovascular Research Group: collaborator
• Cardiovascular Research Foundation, New York: collaborator
• Massachusetts General Hospital: collaborator
• Shockwave Medical, Inc.: lead
• Medpace, Inc.: collaborator

Study Sites (25)

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

NOT YET RECRUITING

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

RECRUITING

University of California Davis

Sacramento, California, 95817, United States

NOT YET RECRUITING

University of California San Diego

San Diego, California, 92037, United States

NOT YET RECRUITING

University of California San Francisco

San Francisco, California, 94121, United States

RECRUITING

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

NOT YET RECRUITING

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

NOT YET RECRUITING

Advocate Health

Park Ridge, Illinois, 60068, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

McLaren Bay

Bay City, Michigan, 48708, United States

RECRUITING

Central Michigan University - Covenant Health

Saginaw, Michigan, 48604, United States

RECRUITING

Allina Health Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

NOT YET RECRUITING

University of Buffalo

Buffalo, New York, 14203, United States

RECRUITING

NYU Langone

New York, New York, 10016, United States

NOT YET RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Weill Cornell Medicine - New York Presbyterian

New York, New York, 10065, United States

NOT YET RECRUITING

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27514, United States

NOT YET RECRUITING

Hatton Research Institution

Cincinnati, Ohio, 45242, United States

RECRUITING

Providence Portland Medical Center

Portland, Oregon, 97213, United States

NOT YET RECRUITING

Main Line Health

Wynnewood, Pennsylvania, 19096, United States

NOT YET RECRUITING

Sanford Health

Sioux Falls, South Dakota, 57105, United States

NOT YET RECRUITING

Baylor Scott & White Dallas

Dallas, Texas, 75226, United States

NOT YET RECRUITING

Baylor Scott & White Plano

Plano, Texas, 75093, United States

NOT YET RECRUITING

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Carotid Artery Diseases; Calcinosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Danilo Romero

CONTACT

+1-510-279-4262; DRomer28@its.jnj.com

Birgit Greschner

CONTACT

+1-510-279-4262; BGreschn@its.jnj.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The objective of the study is to assess the safety and effectiveness of IVL \[Intravascular Lithotripsy\] to treat calcified carotid arteries prior to stenting with commercially available trans-carotid stent systems in patients at high risk for complications from CEA (carotid endarterectomy).

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 14, 2025
• Study Start: June 22, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2032
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (25)