NCT03191500

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Hangzhou Wei Qiang Medical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 .

Detailed 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.

Conditions

• Peripheral Vascular Diseases

Interventions

Type	Name	Description
DEVICE	steerable catheter	peripheral vascular disease

Timeline

• Start date: 2017-07-11
• Primary completion: 2017-11-27
• Completion: 2017-12-31
• First posted: 2017-06-19
• Last updated: 2018-03-21

Locations

1 site across 1 country: China