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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peripheral Vascular Diseases

Intervention / Treatment
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* Device: steerable catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: steerable catheter<br>to study the safety and efficacy of a steerable catheter in the treatment of peripheral vascular disease | Device: steerable catheter<br>* peripheral vascular disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure success rate | The procedure success rate should fulfill the following three point at the same time:1 the steerable catheter can assist the guiding wire into the target vascular. 2 the steerable catheter can follow the guiding wire into the target vascular. 3 the steerable catheter can remove from the subject successfully. | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the steerable catheter compliance during the procedure of catheter access into the target vascular | evaluate with excellent, good , general, poor four levels (according to surgeons experience to score) | during the procedure | 
| the steerable catheter directivity during the procedure of catheter access into the target vascular | evaluate with excellent, good , general, poor four levels (according to surgeons experience to score) | during the procedure | 
| the steerable catheter visibility under the X-ray during the procedure of catheter access into the target vascular | evaluate with excellent, good , general, poor four levels (according to surgeons experience to score) | during the procedure |