Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-22 @ 7:19 PM
Study NCT ID:
NCT02079818
Status:
WITHDRAWN
Last Update Posted:
2019-04-12
First Post:
2014-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System
Sponsor:
Penumbra Inc.
Organization:
Study Overview
Official Title:
CLP 7463: Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System
Status:
WITHDRAWN
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was never initiated.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to gather post market data on the Penumbra Ruby Coil System in the treatment of visceral artery aneurysms and arteriovenous malformations. This study is a prospective, multi-center study of patients with visceral artery aneurysms and visceral arteriovenous malformations who are treated by the Penumbra Ruby Coil System. Data for each patient are collected up to 12 months post-procedure for the study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: