Clinical Trial

Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen

Name: Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen — clinical trial record (NCT07575568)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: REMODEL I

Not Yet Recruiting

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Summary

The objective of this first-in-human study is to assess the safety and effectiveness of the Serranator Sonic Intravascular Lithotripsy (IVL) System™ for the treatment of peripheral artery disease.

Trial Details

NCT Number	NCT07575568
Lead Sponsor	Cagent Vascular LLC Collaborators: Clinical Accelerator, Australian Healthcare Solutions, Yale Cardiovascular Research Group
Conditions	Peripheral Artery Disease
Enrollment	30 participants
Start Date	2026-05
Primary Completion	2026-08 (estimated)
Study Completion	2027-09 (estimated)
Updated on ClinicalTrials.gov	2026-05-08