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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| steerable catheter | Experimental | to study the safety and efficacy of a steerable catheter in the treatment of peripheral vascular disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| steerable catheter | Device | peripheral vascular disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | during the procedure |
| the steerable catheter directivity during the procedure of catheter access into the target vascular |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weiguo Fu, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan hospital Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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evaluate with excellent, good , general, poor four levels (according to surgeons experience to score) |
| 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) | during the procedure |