This is a prospective, multicenter, single-arm clinical trial to evaluate safety and efficacy of a steerable catheter in the establishment of vascular intervention access. five centers participate in this study. The total enrollment number is 68. In the procedure of vascular interventional surgery or angiography diagnosis, the steerable catheter are used to building vascular interventional access. Evaluate the safety and efficacy of the product, by the observation and record the relative index of subjects intraoperative and postoperative (discharge) before and after 30 days .
This is a prospective, multicenter, single-arm clinical trial to evaluate safety and efficacy of a steerable catheter in the establishment of vascular intervention access. five centers participate in this study. The total enrollment number is 68. In the procedure of vascular interventional surgery or angiography diagnosis, the steerable catheter are used to building vascular interventional access. Evaluate the safety and efficacy of the product, by the observation and record the relative index(like catheter compliance, catheter directivity, and catheter visibility under X ray) of subjects in the procedure, telephone follow up at 30 days investigate the subjects healthy condition.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
peripheral vascular disease
Zhongshan hospital Fudan University
Shanghai, Shanghai Municipality, China
procedure success rate
The procedure success rate should fulfill the following three point at the same time:1 the steerable catheter can assist the guiding wire into the target vascular. 2 the steerable catheter can follow the guiding wire into the target vascular. 3 the steerable catheter can remove from the subject successfully.
Time frame: during the procedure
the steerable catheter compliance during the procedure of catheter access into the target vascular
evaluate with excellent, good , general, poor four levels (according to surgeons experience to score)
Time frame: during the procedure
the steerable catheter directivity during the procedure of catheter access into the target vascular
evaluate with excellent, good , general, poor four levels (according to surgeons experience to score)
Time frame: during the procedure
the steerable catheter visibility under the X-ray during the procedure of catheter access into the target vascular
evaluate with excellent, good , general, poor four levels (according to surgeons experience to score)
Time frame: during the procedure
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