Carotid Intravascular Lithotripsy for Carotid Artery Calcification
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called carotid intravascular lithotripsy (IVL) for individuals with calcified carotid arteries, the main blood vessels in the neck that supply blood to the brain. The researchers aim to determine if IVL can safely loosen hard calcium build-up in the arteries before placing a stent, a small tube that keeps the artery open. Suitable candidates have calcified carotid arteries with significant narrowing and face high risks for surgical complications. As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment.
What prior data suggests that the Carotid Intravascular Lithotripsy (IVL) System is safe for treating calcified carotid arteries?
Research has shown that carotid intravascular lithotripsy (IVL) for treating hardened carotid arteries is generally safe and well-tolerated. In one study, the procedure succeeded in all cases, with no neurological issues during or within 30 days after the procedure. Another study found that serious problems like death, stroke, or heart attack were rare, occurring in only 1% to 3.9% of cases.
However, some studies indicate a small risk. Specifically, one study found that 6.8% of patients experienced a new neurological event, such as a stroke or mini-stroke, within 30 days. Despite these risks, IVL remains effective and safe overall, with few adverse events reported.12345Why are researchers excited about this trial?
Carotid Intravascular Lithotripsy (IVL) is unique because it offers a new way to tackle calcified carotid arteries by using sound waves to break up the calcification, which can make stenting easier and safer. Unlike the traditional surgical option, carotid endarterectomy, which involves a more invasive approach to remove plaque, IVL is less invasive and targets the calcification directly within the artery. Researchers are excited because this technique could reduce complications and improve outcomes for patients at high risk for surgery, offering a promising alternative to current treatments.
What evidence suggests that the Carotid Intravascular Lithotripsy (IVL) system is effective for treating calcified carotid arteries?
Research has shown that Carotid Intravascular Lithotripsy (IVL), the treatment under study in this trial, effectively treats hardened carotid arteries. Studies report success in all cases, with no short-term brain-related issues. Specifically, 30-day check-ups revealed low rates of serious problems like stroke or heart attack, ranging from 1% to 3.9%. Another study found very few negative effects, indicating IVL is safe and effective for severe artery hardening. While some concerns exist about possible new brain-related events, the overall evidence supports IVL as a promising treatment option.12345
Are You a Good Fit for This Trial?
This trial is for adults (18+) with significant narrowing and heavy calcium buildup in their internal carotid artery, either with symptoms like stroke or TIA (50%+ blockage) or without symptoms but severe narrowing (70%+). Participants must be able to follow study procedures and have a life expectancy over one year.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravascular lithotripsy (IVL) for calcified carotid arteries prior to stenting
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carotid Intravascular Lithotripsy (IVL)
Trial Overview
The study tests the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System, which uses sound waves to break up calcium in blocked neck arteries before placing a stent. All participants receive this treatment at multiple centers.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shockwave Medical, Inc.
Lead Sponsor
Cardiovascular Research Foundation, New York
Collaborator
Massachusetts General Hospital
Collaborator
Medpace, Inc.
Industry Sponsor
Dr. August J. Troendle
Medpace, Inc.
Chief Executive Officer since 1992
MD from the University of Maryland, School of Medicine; MBA from Boston University
Dr. Reinilde Heyrman
Medpace, Inc.
Chief Medical Officer since 2017
MD
Yale Cardiovascular Research Group
Collaborator
Citations
Intravascular lithotripsy-assisted carotid artery stenting ... - PMC
Technical success was achieved in all cases, with no neurological complications noted during the perioperative period, 30-day follow-up
Off-label use of intravascular lithotripsy in severely calcified ...
The findings suggest that IVL could be a valuable adjunct in the treatment of severely calcified carotid artery stenosis, potentially reducing ...
IVL for Dense, Complex Carotid Artery Disease
More recent CAS trials have shown an improvement in 30-day death/stroke and death/stroke/myocardial infarction rates, ranging from 1% to 3.9%,
Multi-center experience with intravascular lithotripsy for ...
Four patients (6.8%) sustained any new neurological event (stroke/transient ischemic attack) within 30 days, raising concerns
Intravascular lithotripsy followed by angioplasty and ...
Intravascular lithotripsy for treatment of calcified lesions during carotid artery stenting. J Endovasc Ther. (2020) 28:93–9. doi: 10.1177/1526602820954244.
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