Evaluate the Safety and Efficacy of a Steerable Catheter in the Treatment of Vascular Interventional Access
NCT03191500 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2018-03-21
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 .
Conditions
- Peripheral Vascular Diseases
Interventions
- DEVICE
-
steerable catheter
peripheral vascular disease
Sponsors & Collaborators
-
Hangzhou Wei Qiang Medical Technology Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Weiguo Fu, MD · Fudan University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-07-11
- Primary Completion
- 2017-11-27
- Completion
- 2017-12-31
Countries
- China
Study Locations
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