Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-25 @ 2:26 PM
Study NCT ID:
NCT03420066
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2018-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The NEXUS™ Compassionate Use Data Collection Study
Sponsor:
Endospan Ltd.
Organization:
Study Overview
Official Title:
NEXUS™ Aortic Arch Stent Graft System Data Collection Study for Compassionate-Use Procedures
Status:
COMPLETED
Status Verified Date:
2024-01
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:
None
Brief Summary:
A Multicenter, observational Data Collection Study to Evaluate the Safety and Performance of the Nexus™ Aortic Arch Stent Graft System in patients that were implanted with the device as part of Compassionate Use Procedures.
Detailed Description:
The purpose of the study is to collect and analyze data that is recorded as standard of care for patients that were implanted with the Nexus device as part of Compassionate Use Procedures.The data will be used to obtain additional information on the safety and performance of the Nexus™ Aortic Arch Stent Graft System in patients affected by pathologies involving the aortic arch.
Data will be collected at each time point of patient's follow up conducted according to the standard of care in each site.
Data will be collected at each time point of patient's follow up conducted according to the standard of care in each site.
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?:
None
Is an FDA AA801 Violation?: