At a glance
ClinicalIndex Comparison RecordN/ACompleted· 145 enrolled
Drug / intervention
IVL with Shockwave C2+ 2Hz Coronary IVL Catheterdevice
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 IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD Duo Study)
In Brief
A clinical study evaluating IVL with Shockwave C2+ 2Hz Coronary IVL Catheter for Coronary Artery Disease and Myocardial Infarction. Completed, enrolled 145 participants across 18 sites.
Detailed Summary
This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo, calcified, stenotic, coronary lesions prior to stenting.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Myocardial Infarction
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
202420252026
First PostedAug 2023
Enrollment StartDec 2023
Primary CompletionJan 2025
Study CompletionDec 2025
TodayJul 2026
First PostedAug 1, 2023
Enrollment StartDec 8, 2023
Primary CompletionJan 9, 2025
Study CompletionDec 19, 2025
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 2.9 years ago
Interventions
IVL with Shockwave C2+ 2Hz Coronary IVL Catheterdevice
Lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.