At a glance
ClinicalIndex Comparison RecordN/ACompleted· 431 enrolled
Drug / intervention
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.
Prospective, Multicenter, Single-Arm, Global IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2 Coronary IVL Catheter in Calcified Coronary Arteries
In Brief
A clinical study evaluating Lithotripsy for Coronary Artery Disease and Myocardial Infarction. Completed, enrolled 431 participants across 48 sites in 4 countries.
Detailed Summary
The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting. Disrupt CAD III is being conducted as a staged pivotal study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Myocardial Infarction
CountriesFrance, Germany, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 2018
Enrollment StartJan 2019
Primary CompletionMay 2020
Study CompletionApr 2022
TodayJul 2026
First PostedJul 23, 2018
Enrollment StartJan 9, 2019
Primary CompletionMay 7, 2020
Study CompletionApr 10, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.9 years ago
Interventions
Lithotripsydevice
Deliver Lithotripsy to the target vessel prior to placing a coronary stent.