Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-02-28 @ 10:53 PM
Study NCT ID:
NCT04090320
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2019-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CATERPILLAR™ Arterial Embolization Device Study
Sponsor:
C. R. Bard
Organization:
Study Overview
Official Title:
A Prospective, Multi-Center, Single-Arm Study Assessing the Clinical Use of the CATERPILLAR™ Arterial Embolization Device System for Arterial Embolization in the Peripheral Vasculature (CHRYSALIS)
Status:
COMPLETED
Status Verified Date:
2021-01
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:
CHRYSALIS
Brief Summary:
The primary objective of this study is to evaluate the performance and safety of the CATERPILLAR™ Arterial Embolization Device when used for arterial embolization in the peripheral vasculature.
Detailed Description:
This feasibility study is a prospective, multi-center, single-arm study of the CATERPILLAR™ Arterial Embolization Device. Up to twenty (20) subjects will be treated with the CATERPILLAR™ Arterial Embolization Device at up to 5 investigational sites in New Zealand and Australia.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: