CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled / 35 target
Drug / intervention
Shockwave Medical Mini S Peripheral IVL Catheterdevice
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/NCT05058456
NCT05058456N/ACompletedMonitor (0.7/mo)Completion was 30mo ago
CompareCT.gov

Prospective, Multi-center, Single-arm Feasibility Study of the Shockwave Medical Mini S Peripheral Intravascular Lithotripsy (IVL) System

Shockwave Medical, Inc.·interventional·Posted Sep 27, 2021·Updated Jun 8, 2026

In Brief

A clinical study evaluating Shockwave Medical Mini S Peripheral IVL Catheter for Peripheral Arterial Disease. Completed, enrolled 35 participants across 4 sites in 2 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

Prospective, multi-center, single-arm feasibility study to assess the safety and performance 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
CountriesAustralia, New Zealand
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedSep 27, 2021
Enrollment StartMar 16, 2022
Primary CompletionDec 19, 2023
Study CompletionDec 5, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.8 years ago

Arms & Interventions

Single-armexperimental

Device: Shockwave Medical Mini S Peripheral IVL Catheter

Interventions

Shockwave Medical Mini S Peripheral IVL Catheterdevice

The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.