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185 Participants NeededMy employer runs this trial

Carotid Intravascular Lithotripsy for Carotid Artery Calcification

Recruiting at 24 trial locations
DR
BG
Overseen ByBirgit Greschner
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Shockwave Medical, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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)

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

My artery blockage can be treated with one standard trans-carotid stent.
I have a severe (70% or more) narrowing in my carotid artery but no symptoms.
My scan shows a thick calcified area in my narrowed blood vessel.
See 7 more

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

Group I: Calcified Carotid ArteryExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shockwave Medical, Inc.

Lead Sponsor

Trials
38
Recruited
10,200+

Cardiovascular Research Foundation, New York

Collaborator

Trials
28
Recruited
27,800+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

Medpace, Inc.

Industry Sponsor

Trials
98
Recruited
30,400+

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

Trials
11
Recruited
4,000+

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