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

NCT ID: NCT03191500

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-11
• Study Completion Date: 2017-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

steerable catheter

to study the safety and efficacy of a steerable catheter in the treatment of peripheral vascular disease

Group Type: EXPERIMENTAL

steerable catheter

Intervention Type: DEVICE

peripheral vascular disease

Interventions

steerable catheter

peripheral vascular disease

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• age from 18 to 80, male or female.
• Complying with the standard of peripheral vascular interventional operation treatment , complying with the standard treatment of vascular angiogram, need to establish vascular interventional treatment access.
• The subject who is able to understand the test purpose, voluntarily join this clinical trial with informed consent forms.

Exclusion Criteria

• Patients with cerebrovascular accident or major gastrointestinal bleeding in six months unable to carry out antithrombotic therapy because of having contraindications to antiplatelet agents and anticoagulants and have haemorrhage tendency
• Hypohepatia, hematuria, deep vein thrombosis, and/or receiving the immunosuppressant therapy
• The distal target vessel blood flow low may produce thrombosis
• The women who pregnancy, lactation and can't contraception during the trial period
• Patients has been involved in other drugs or medical devices clinical trials related to treatment of the target lesion or has been involved in other drugs or medical device clinical trials but have not reached the primary endpoint of the study
• Patients unable or unwilling to participate in this trial
• the researcher determine the patient is not suitable to participate in clinical research

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Wei Qiang Medical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weiguo Fu, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Zhongshan hospital Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

LT002

Identifier Type: -

Identifier Source: org_study_id