CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 37 enrolled
Drug / intervention
Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL)device
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/NCT04585763
NCT04585763N/ACompleted
CompareCT.gov

Prospective, Multi-center, Single-arm Study of the Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) System in Calcified Peripheral Arteries

Shockwave Medical, Inc.·interventional·Posted Oct 14, 2020·Updated Jan 3, 2024

In Brief

A clinical study evaluating Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL) for Peripheral Arterial Disease and Vascular Disease, Peripheral. Completed, enrolled 37 participants across 8 sites in 3 countries.

Detailed Summary

Prospective, multi-center, single-arm study of the M5+ Peripheral IVL system to treat calcified peripheral arteries.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease, Vascular Disease, Peripheral
CountriesAustralia, New Zealand, United States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 14, 2020
Enrollment StartFeb 16, 2021
Primary CompletionAug 25, 2021
Study CompletionNov 21, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.7 years ago

Interventions

Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL)device

The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.