Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04545112
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-01-26
First Post:
2020-08-28
Brief Title:
Xeltis Coronary Artery Bypass Graft XABG First in Human FIH
Sponsor:
Xeltis
Organization:
Xeltis
Study Overview
Official Title:
Prospective Non-randomized First in Human FIH Clinical Study to Assess the Feasibility of the Novel Xeltis Coronary Artery Bypass Graft XABG
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-01
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:
XABG-FIH
Brief Summary:
A FIH study to collect preliminary device safety feasibility and performance data of the XABG in patients with symptomatic coronary artery disease SCAD with suitable multi vessel disease MVD and selected by the local Heart Team for elective coronary artery bypass grafts surgery of at least 3 bypass grafts minimally 1 artery and 2 veins or 2 arteries and 1 vein
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None