Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
Study NCT ID:
NCT05874206
Status:
RECRUITING
Last Update Posted:
2025-02-26
First Post:
2023-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CRATOS - Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions
Sponsor:
Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
Organization:
Study Overview
Official Title:
Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The goal of this prospective, interventional, multicentre, single-arm performance objective study is to evaluate efficacy and safety of Cratos™ Branch Stent Graft System in treatment of lesions (dissection, IMH and PAU in descending aorta. The main question\[s\] it aims to answer are:
* 30-day all-cause Mortality rate
* Composite of the following events from the time of enrolment through 12-month:
* Device Technical Success
* Absence of: Aortic rupture, Lesion-related mortality, Disabling Stroke, Permanent paraplegia, Permanent paraparesis, New onset renal failure requiring permanent dialysis, Additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the device system
Participants will come for hospital office visits 1, 6, 12, 24-, 36-, 48- and 60-months post-procedure for the following, but not limited to assessments:
* Physical examination
* Modified Rankin scale
* Tarlov scoring scale
* CTA
* 30-day all-cause Mortality rate
* Composite of the following events from the time of enrolment through 12-month:
* Device Technical Success
* Absence of: Aortic rupture, Lesion-related mortality, Disabling Stroke, Permanent paraplegia, Permanent paraparesis, New onset renal failure requiring permanent dialysis, Additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the device system
Participants will come for hospital office visits 1, 6, 12, 24-, 36-, 48- and 60-months post-procedure for the following, but not limited to assessments:
* Physical examination
* Modified Rankin scale
* Tarlov scoring scale
* CTA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: