At a glance
ClinicalIndex Comparison RecordN/ACompleted· 72 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 Study of the SWM-1234 in Calcified Coronary Arteries (Disrupt CAD IV Study - Japan)
In Brief
A clinical study evaluating Lithotripsy for Coronary Artery Disease and Myocardial Infarction. Completed, enrolled 72 participants across 8 sites.
Detailed Summary
The study design is a prospective, multicenter, single-arm 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Myocardial Infarction
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
First PostedNov 2019
Enrollment StartNov 2019
Primary CompletionMay 2020
Study CompletionMar 2022
TodayJul 2026
First PostedNov 5, 2019
Enrollment StartNov 6, 2019
Primary CompletionMay 8, 2020
Study CompletionMar 25, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.7 years ago
Interventions
Lithotripsydevice
Deliver Lithotripsy to the target vessel prior to placing a coronary stent