MedTrace Logo

A Study to Evaluate the Safety and Effectiveness of the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System in Adults With Peripheral Artery Disease (PAD)

NCT07209085 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-10-09

No results posted yet for this study

Summary

The purpose of this clinical study is to learn if the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System is safe and works well to help people with peripheral artery disease (PAD) who have hard, calcium-filled blockages in their leg arteries.

The study will test the idea that using sound waves inside the artery can safely break up calcium and make it easier to open the artery so blood can flow better.

The main question this study is trying to answer is:

Can treatment with the FastWave Artero™ IVL System safely widen blocked leg arteries and lower the chance of serious problems during or after the procedure?

About 110 adults at up to 30 medical centers in the United States will take part. Everyone in the study will receive the IVL treatment.

During the study, participants will:

Have a minimally invasive procedure using the FastWave IVL System

Stay for a short observation period after the procedure

Return for follow-up visits about 30 days and 6 months later

Researchers will look at how well the arteries open, how long they stay open, and whether any major complications occur. The results will help determine if the FastWave Artero™ IVL System can be used as a safe and effective treatment for people with PAD and severe calcium buildup in the leg arteries.

Conditions

  • Peripheral Artery Disease (PAD)

Interventions

DEVICE

FastWave Artero™ Peripheral IVL System

The FastWave Artero™ Peripheral IVL System includes a generator and a balloon-based catheter designed to treat calcified blockages in peripheral arteries. During a single endovascular index procedure, the catheter is positioned within the target femoropopliteal artery and inflated at low pressure. The device emits short bursts of pulsatile sonic pressure waves that fracture calcium deposits, improving vessel flexibility and allowing dilation at low balloon pressures to restore blood flow. Multiple inflations may be performed as needed. Adjunctive angioplasty or stenting may be used at the investigator's discretion.

Sponsors & Collaborators

  • Rede Optimus Hospitalar SA

    collaborator NETWORK

  • Medical Metrics Diagnostics, Inc

    collaborator INDUSTRY

  • FastWave Medical

    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
2025-12-31
Primary Completion
2026-09-30
Completion
2027-03-31
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 NCT07209085 on ClinicalTrials.gov