Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the T… (NCT07062471) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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)
185 participantsStarted 2026-05
Plain-language 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)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 approved for inclusion by a Patient Screening Committee.
✓. 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:
Exclusion criteria
✕. 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
What they're measuring
1
Composite endpoint with death, stroke, or myocardial infarction (MI) [Safety]
✕. 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.