CATCH [Short Name for: Coil Application Trial in China]
Condition: Intracranial Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional

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 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.
    

Intervention name(s): Coil Embolization System; Cotrol device from Medronic
Intervention type(s): Device; Device
Intervention description(s): 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.; Control device from Medronic (include AxiumTM Detachable Coils and AxiumTM Prime Detachable Coils) are manufactured by ev3 (Medtronic, Irvine, California, USA);
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coils