CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 250 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/NCT05007925
NCT05007925N/ACompleted
CompareCT.gov

Prospective, Multi-center, Single-arm Study of the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System for Treatment of Calcified Peripheral Arterial Disease (PAD) in Below-the-Knee (BTK) Arteries

Shockwave Medical, Inc.·interventional·Posted Aug 17, 2021·Updated May 5, 2026

In Brief

A clinical study evaluating Intravascular Lithotripsy for Peripheral Artery Disease. Completed, enrolled 250 participants across 43 sites in 2 countries.

Detailed Summary

To assess the continued safety, effectiveness, and optimal clinical use of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries. Post-market, prospective , multi-center, single-arm study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Artery Disease
CountriesGermany, United States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 17, 2021
Enrollment StartNov 18, 2021
Primary CompletionMar 25, 2024
Study CompletionMar 27, 2026
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 4.9 years ago

Interventions

Intravascular Lithotripsydevice

Localized peripheral intravascular lithotripsy