CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Shockwave Coronary Rx Lithoplasty® 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/NCT02650128
NCT02650128N/ACompleted
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Prospective Multi-Center, Single Arm Study of the Shockwave Coronary Rx Lithoplasty® System in Coronary Arteries

Shockwave Medical, Inc.·interventional·Posted Jan 8, 2016·Updated Nov 2, 2018

In Brief

A clinical study evaluating Shockwave Coronary Rx Lithoplasty® System for Coronary Artery Disease. Completed, enrolled 60 participants across 7 sites in 5 countries.

Detailed Summary

Prospective, multi-center, single arm study designed to evaluate the safety and performance of the Shockwave Coronary Rx Lithoplasty® System to treat calcified lesions in the coronary arteries for the purpose of enhancing the placement of stents and reducing the ultimate residual stenosis. Patients will be followed through discharge and at 30 and 180 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesAustralia, France, Netherlands, Sweden, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 8, 2016
Enrollment StartDec 1, 2015
Primary CompletionSep 1, 2016
Study CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.5 years ago

Interventions

Shockwave Coronary Rx Lithoplasty® Systemdevice

The Shockwave Coronary Rx Lithoplasty® System is a proprietary balloon catheter system designed to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic, de novo coronary arteries. Energizing the lithotripsy electrodes will generate pulsatile mechanical energy within the target treatment site and will disrupt calcium within the lesion and allow subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of a rapid exchange balloon catheter with integrated, internal lithotripsy electrodes and a Shockwave generator.