Ignite Creation Date:
2024-05-06 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03595176
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2018-06-22
Brief Title:
Disrupt CAD III With the Shockwave Coronary IVL System
Sponsor:
Shockwave Medical Inc
Organization:
Shockwave Medical Inc
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-05
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 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
Detailed Description:
Subject Population Subjects 18 years of age with de novo calcified coronary artery lesions presenting with stable unstable or silent ischemia that are suitable for percutaneous coronary intervention PCI Approximately 392 subjects at 50 sites will be enrolled A minimum of 50 of the total enrollment will come from the United StatesSubjects will be followed through discharge 30 days 6 12 and 24 months
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