At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,212 enrolled
Drug / intervention
Shockwave C2 Coronary IVLdevice
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.
New Enrollment Post Approval Registry for the Shockwave Intravascular Lithotripsy (IVL) System With Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
In Brief
An observational study evaluating Shockwave C2 Coronary IVL for Coronary Artery Disease and Myocardial Infarction. Completed, enrolled 1,212 participants across 1 site.
Detailed Summary
The study design is a prospective, multicenter, observational, single-arm post-approval study using data collected in the National Cardiovascular Data Registry (NCDR®) CathPCI Registry®.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Myocardial Infarction
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
Enrollment StartMar 2021
First PostedAug 2021
Primary CompletionMar 2022
TodayJul 2026
First PostedAug 25, 2021
Enrollment StartMar 10, 2021
Primary CompletionMar 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.9 years ago
Interventions
Shockwave C2 Coronary IVLdevice
PCI procedure using a Shockwave C2 coronary IVL catheter