CATCH [Short Name for: Coil Application Trial in China] (CATCH)
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|ClinicalTrials.gov Identifier: NCT02990156|
Recruitment Status : Active, not recruiting
First Posted : December 13, 2016
Last Update Posted : August 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Aneurysm||Device: Coil Embolization System Device: Cotrol device from Medronic||Not Applicable|
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 5.1 to 19.6 cases per 100,000 persons. With the development of imaging technology and the greater attention paid by people to their overall health,there 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||336 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 8, 2017|
|Actual Primary Completion Date :||March 25, 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: Coil Embolization System
Coil Embolization System,or deposits coils in the aneurysm sac by electrolytical detachment; coil types include Complex Finish, Complex Frame,and Helical. The coils are made of a platinum - tungsten alloy, have a minimum diameter of 2 mm and a maximum diameter of 24mm.
Device: Coil Embolization System
deposits coils in the aneurysm sac by electrolytical detachment; coil types include Complex Finish, Complex Frame, and Helical. The coils are made of a platinum - tungsten alloy, have a minimum diameter of 2 mm and a maximum diameter of 24mm. The intended use of the Microport NeuroTech Coil Embolization System is for the endovascular embolization of intracranial aneurysms.
Active Comparator: Control device from Medronic
Control device from Medronic,include AxiumTM Detachable Coils and AxiumTM Prime Detachable Coils, which are manufactured by ev3 (Medtronic, Irvine, California, USA);
Device: Cotrol device from Medronic
Control device from Medronic (include AxiumTM Detachable Coils and AxiumTM Prime Detachable Coils) are manufactured by ev3 (Medtronic, Irvine, California, USA);
- Raymond Scale [ Time Frame: 6 Months ]For the MicroPort NeuroTech Coil Embolization System, this endpoint will be based upon the 6-month Core Lab identification of patients with "Successful occlusion" rate: % of subjects who at 6 months' post coiling, reported as a combination of Raymond 1 and Raymond 2 outcomes (95%-100%). The endpoint will be expressed as a percentage of all evaluable subjects with complete and nearly complete (95%-100%) occlusion in the context of the whole population of evaluable subjects (n/N).
- Modified Rankin Scale [ Time Frame: 6 Months ]
6-months post-treatment "Clinical Worsening", "Clinical Worsening" will be calculated as the percentage of subjects who meet the following condition: Final mRS score is more than 2 and is at least 1 point higher than the pre study measurement.
For most subjects, this will be determined at the 6-months follow up visit. However, for those subjects whose trial participation is prematurely shortened, as a result of death (mRS will count as 6) or very serious device or procedure related debilitating injury, their final mRS determination will be counted, as the most recent score at the time of leaving the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990156
|Shanghai, Shanghai, China, 201318|
|Principal Investigator:||Jianmin LIU, MD||Xinhua Hospital, Shanghai Jiao Tong University School of Medicine|