Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT05858905
Status:
COMPLETED
Last Update Posted:
2025-06-26
First Post:
2023-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter
Sponsor:
Shockwave Medical, Inc.
Organization:
Study Overview
Official Title:
Forward-Shifted Intravascular Lithotripsy (IVL) Technology in a Prospective, Multi-center, Single-arm Investigational Device Exemption (IDE) Study
Status:
COMPLETED
Status Verified Date:
2025-06
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:
FORWARD PAD
Brief Summary:
The FORWARD PAD IDE Study is a prospective, multi-center, single-arm investigational device exemption study, conducted to assess the safety and effectiveness of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: