Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520774
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-07
Brief Title:
Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Multicenter Single-Group Target-Value Clinical Trial Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the study is to evaluate the safety and efficacy of the Lifetech Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
Detailed Description:
The physician must strictly adhere to the clinical study protocol and shall not deviate from or substantially alter it However in cases of emergency where there is an immediate risk to the subjects that must be eliminated immediately a report may be submitted in written form afterward During the study any amendments to the clinical study protocol informed consent documents requests for deviation and the resumption of a suspended clinical study must receive written approval from the Ethics Committee
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None