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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) | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

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)

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)

NCT07062471•Shockwave Medical, Inc.

View on ClinicalTrials.gov

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)

Detailed Description

To assess the safety and effectiveness of the Shockwave Medical SkyRunner Carotid IVL System for the treatment of calcified carotid arteries prior to stenting with commercially available trans-carotid stent systems in patients at high risk for complications from carotid endarterectomy (CEA). Up to 160 subjects will be enrolled at up to 25 sites in the United States (US). The estimated study duration is approximately 40 months. Study subjects will be followed through discharge, 30 days, 6, 12, and 24 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years.
•2. Patient is able and willing to comply with all assessments in the study.
•3. Patient has been informed of the nature of the study, agrees to participate and has signed the approved informed consent form.
•4. Patient approved for inclusion by a Patient Screening Committee.
•5. Patient must have a life expectancy \> 1 year at the time of the index procedure with no planned major cardiac intervention or surgery within 30 days following the index procedure.
•6. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the carotid bifurcation.
•7. 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.
•8. 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:
•1. 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.
•OR
+23 more criteria

Exclusion Criteria

•1. Patient has alternative source of cerebral embolus, including but not limited to:
•1. a history of chronic atrial flutter or atrial fibrillation, or paroxysmal atrial flutter or atrial fibrillation requiring chronic anticoagulation
•2. 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)
•3. recently (\< 60 days) replaced/repaired heart valve (either surgically or percutaneously).
•2. 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.
•3. Patient with a history of major stroke with substantial neurological deficit (NIHSS ≥ 5 or mRS ≥ 3) within 1 month of index procedure.
•4. Patient has had a TIA, or amaurosis fugax within 48 hours prior to the procedure.
•5. 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.
•6. Patient has an intracranial tumor.
•7. Patient has an isolated hemisphere.
+19 more criteria

Key Dates

Start Date

January 1, 2026

Primary Completion Date

May 1, 2027

Completion Date

June 1, 2029

Last Updated

July 14, 2025

Enrollment

160

ESTIMATED participants

Conditions

Carotid Artery CalcificationCarotid Artery Diseases

Interventions

Carotid Intravascular Lithotripsy (IVL)

DEVICE

Contacts

Danilo Romero

CONTACT

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

Birgit Greschner

CONTACT

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

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

NCT07322913

Carotid Artery DiseasesAortic Diseases+1 more

View study

RECRUITINGNA

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 Approach

NCT06653387

Carotid Artery Diseases

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

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 Approach

Change of Hemodynamics and Cerebral Functions After Carotid Artery Revascularization

Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III)

Immunomodulatory Effects of PCSK9 Inhibition

The VANGAS-Trial. The Value of Neurofilament Light Chain and Glial Fibrillary Acid Protein in the Blood of Patients With Asymptomatic Carotid Artery Stenosis