The CiTop™ guidewire Coronary study is a feasibility open label study, to evaluate the safety and efficacy of the CiTop™ Guidewire for crossing chronic total occlusion in Coronary arteries.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
CiTop(tm)6 Guidewire
S.A.L Hospital
Ahmedabad, Gujarat, India
Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications.
Time frame: during procedure, 1day, 1week and 30 days post procedure
Successful stenting
Time frame: During procedure, Day1, Day7 and Day30 post procedure
Wire crossing duration
Time frame: during procedure
Fluoroscopy time
Time frame: during procedure
Amount of contrast
Time frame: during procedure
Maneuverability of the CiTop™ up to the occlusion
Time frame: during procedure
No mechanical damage to the device during
Time frame: during procedure
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