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

Hangzhou Wei Qiang Medical Technology

Status

Completed

Conditions

Peripheral Vascular Diseases

Treatments

Device: steerable catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT03191500

LT002

Details and patient eligibility

About

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 .

Full 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.

Enrollment

72 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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