Medpace Holdings Inc ((MEDP)) announced an update on their ongoing clinical study.
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Study Overview: The SKYWARD Trans-Carotid IDE Study, officially titled ‘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,’ aims to evaluate the safety and effectiveness of the IVL system in treating calcified carotid arteries before stenting. This study is significant as it targets patients at high risk for complications from carotid endarterectomy, potentially offering a safer alternative.
Intervention/Treatment: The intervention being tested is the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System. This device is designed for lithotripsy-enhanced balloon dilatation of calcified lesions in the carotid arteries, preparing them for stenting.
Study Design: This interventional study follows a single-group model, focusing on treatment. There is no masking involved, meaning all participants and researchers are aware of the treatment being administered. The primary purpose is to assess treatment efficacy and safety.
Study Timeline: The study is not yet recruiting, with the initial submission date set for June 30, 2025, and the last update on July 10, 2025. These dates mark the administrative progress and readiness for participant recruitment.
Market Implications: This study update could influence Medpace Holdings Inc’s stock performance positively, as successful outcomes may enhance their reputation in cardiovascular research. It also positions Shockwave Medical, Inc. as a key player in innovative cardiovascular treatments, potentially affecting investor sentiment and market dynamics in the medical device industry.
The study is ongoing, with further details available on the ClinicalTrials portal.