Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-25 @ 2:42 PM
Study NCT ID:
NCT05112250
Status:
COMPLETED
Last Update Posted:
2021-11-08
First Post:
2021-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IVL for Stent Underexpantsion
Sponsor:
Medical University of Silesia
Organization:
Study Overview
Official Title:
Intravascular Lithotripsy for the Treatment of Stent Underexpansion: the Multicenter IVL-DRAGON Registry
Status:
COMPLETED
Status Verified Date:
2021-11
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:
IVL-DRAGON
Brief Summary:
The IVL-Dragon Registry was a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL in high-volume PCI centers. The primary efficacy endpoint was clinical success, defined as a reduction of stent underexpansion to \<30% with no evidence of in-hospital device-oriented composite end point (DOCE) (defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: