CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
IVL Coronary Lithotripsy Systemdevice
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/NCT03328949
NCT03328949N/ACompleted
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Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries

Shockwave Medical, Inc.·interventional·Posted Nov 1, 2017·Updated Nov 19, 2019

In Brief

A clinical study evaluating IVL Coronary Lithotripsy System for Coronary Artery Disease. Completed, enrolled 120 participants across 15 sites in 9 countries.

Detailed Summary

The objective of this post market study is to examine the safety and performance of the Shockwave Coronary Intravascular Lithotripsy System for the treatment of narrowed coronary arteries before the doctor places a stent.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesBelgium, Denmark, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 1, 2017
Enrollment StartMay 18, 2018
Primary CompletionMar 26, 2019
Study CompletionApr 25, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.7 years ago

Interventions

IVL Coronary Lithotripsy Systemdevice

The coronary intravascular lithotripsy catheter is similar to other balloon devices that are routinely used during angioplasty procedures; however, it has electrodes inside the balloon which are designed to deliver energy to crack the calcified blockage using lithotripsy (acoustic energy).