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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)

NCT07062471 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2026-04-03

No results posted yet for this study

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

Interventions

DEVICE

Carotid Intravascular Lithotripsy (IVL)

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.

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Yale Cardiovascular Research Group

    collaborator OTHER

  • Cardiovascular Research Foundation, New York

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Shockwave Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-10-31
Completion
2032-10-31
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07062471 on ClinicalTrials.gov