Ignite Creation Date:
2024-05-06 @ 4:33 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05021757
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2021-08-03
Brief Title:
Disrupt CAD III Post-Approval Study PAS
Sponsor:
Shockwave Medical Inc
Organization:
Shockwave Medical Inc
Study Overview
Official Title:
New Enrollment Post Approval Registry for the Shockwave Intravascular Lithotripsy IVL System With Shockwave C2 Coronary Intravascular Lithotripsy IVL Catheter
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Subject Population Patients 18 years of age with severely calcified stenotic de novo coronary artery lesions presenting with stable unstable or silent ischemia that are suitable for percutaneous coronary intervention PCI and with clinical characteristics similar to the Disrupt CAD III IDE study Approximately 1000 patients in the CathPCI Registry including a minimum of 30 patients with permanent pacemakers PPM or implantable cardioverter defibrillators ICDs will be enrolled Subjects will be followed through discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None