Ignite Creation Date:
2024-05-06 @ 9:30 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02990156
Status:
COMPLETED
Last Update Posted:
2022-04-14
First Post:
2016-12-01
Brief Title:
CATCH Short Name for Coil Application Trial in China
Sponsor:
MicroPort NeuroTech Co Ltd
Organization:
MicroPort NeuroTech Co Ltd
Study Overview
Official Title:
Prospective Randomized Controlled Open Label All China Multi-Center Registration Trial of the MICROPORT NEUROTECH Coil Embolization System for the Traetment of Intracranial Aneurysms
Status:
COMPLETED
Status Verified Date:
2022-04
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:
CATCH
Brief Summary:
The scope of this trial is the collection and analysis of effectiveness and safety endpoints related to the use of the MicroPort NeuroTech Coil Embolization System in the treatment of intracranial aneurysms
Detailed Description:
A cerebral aneurysm also known as an intracranial or intracerebral aneurysm is a weak or thin spot on a blood vessel in the brain that balloons out and fills and intermixes with parent artery blood Aneurysms can occur at any age Global incidence varies by country with reports of prevalence ranging from 51 to 196 cases per 100000 persons With the development of imaging technology and the greater attention paid by people to their overall healththere will be more aneurysms be detected The combination of sophisticated imaging equipment more frequent use of imaging in patients and the aforementioned emphasis on optimum health has led to a greater proportion of asymptomatic aneurysms being discovered
The most common type of aneurysms are saccular and aneurysms are more likely to occur in women The most devastating presentation of an intracranial aneurysm is subarachnoid hemorrhage SAH It is estimated that on average five percent of the population is afflicted and the incidence of aneurysm rupture SAH is between 6 and 9 per 1000 000 individuals Mortality can approach 50 with fewer than 60 of survivors returning to independent living
Invasive treatment of aneurysms began with an open surgical procedure referred to as surgical clipping This treatment was once considered the gold standard treatment for aneurysms The first neurovascular interventional medical device was the Guglielmi Detachable Coil GDC which was developed and tested in the mid-1990s and was introduced by Dr Guido Guglielmi and Target Therapeutics Fremont California These bare platinum coils were electrolytically detached for placement in the aneurysm sac It took approximately one decade to prove coiling superiority over surgical clipping after publication of the results of the ISAT Study Since that time coils have become more sophisticated in makeup and conformation Coil use is also a mainstay for neurovascular procedures
The most common type of aneurysms are saccular and aneurysms are more likely to occur in women The most devastating presentation of an intracranial aneurysm is subarachnoid hemorrhage SAH It is estimated that on average five percent of the population is afflicted and the incidence of aneurysm rupture SAH is between 6 and 9 per 1000 000 individuals Mortality can approach 50 with fewer than 60 of survivors returning to independent living
Invasive treatment of aneurysms began with an open surgical procedure referred to as surgical clipping This treatment was once considered the gold standard treatment for aneurysms The first neurovascular interventional medical device was the Guglielmi Detachable Coil GDC which was developed and tested in the mid-1990s and was introduced by Dr Guido Guglielmi and Target Therapeutics Fremont California These bare platinum coils were electrolytically detached for placement in the aneurysm sac It took approximately one decade to prove coiling superiority over surgical clipping after publication of the results of the ISAT Study Since that time coils have become more sophisticated in makeup and conformation Coil use is also a mainstay for neurovascular procedures
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