CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
Intravascular Lithotripsydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05858905
NCT05858905N/ACompleted
CompareCT.gov

Forward-Shifted Intravascular Lithotripsy (IVL) Technology in a Prospective, Multi-center, Single-arm Investigational Device Exemption (IDE) Study

Shockwave Medical, Inc.·interventional·Posted May 15, 2023·Updated Jun 26, 2025

In Brief

A clinical study evaluating Intravascular Lithotripsy for Peripheral Arterial Disease. Completed, enrolled 55 participants across 21 sites.

Detailed Summary

The FORWARD PAD IDE Study is a prospective, multi-center, single-arm investigational device exemption study, conducted to assess the safety and effectiveness of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedMay 15, 2023
Enrollment StartJun 27, 2023
Primary CompletionApr 5, 2024
Study CompletionApr 21, 2025
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.1 years ago

Interventions

Intravascular Lithotripsydevice

The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature.