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

NCT07575568 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Serranator Sonic Intravascular Lithotripsy (IVL) System

Serration remodeling balloon angioplasty with Intravascular Lithotripsy of the superficial femoral and popliteal arteries for Cohort A: Above-the-Knee; treatment of the infrapopliteal and inframalleolar arteries for Cohort B: Below-the-Knee.

Sponsors & Collaborators

  • Clinical Accelerator

    collaborator INDUSTRY

  • Australian Healthcare Solutions

    collaborator UNKNOWN

  • Yale Cardiovascular Research Group

    collaborator OTHER

  • Cagent Vascular LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2026-08-31
Completion
2027-09-30
FDA Device
Yes

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Entities

Diseases

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 NCT07575568 on ClinicalTrials.gov