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Evaluate the Safety and Efficacy of a Steerable Catheter in the Treatment of Vascular Interventional Access

Peripheral Vascular Diseases Clinical Trial

Official title:
Evaluate the Safety and Efficacy of a Steerable Catheter in the Treatment of Vascular Interventional Access : a Prospective, Muti-center, Single-arm Study

Clinical Trial Summary

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 .

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03191500
Study type Interventional
Source Hangzhou Wei Qiang Medical Technology Co., Ltd.
Contact
Status Completed
Phase N/A
Start date July 11, 2017
Completion date December 31, 2017
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