Clinical trial NCT03191500: Evaluate the Safety and Efficacy of a Steerable Catheter in the Treatment of Vascular Interventional Access
Official title: Evaluate the Safety and Efficacy of a Steerable Catheter in the Treatment of Vascular Interventional Access : a Prospective, Muti-center, Single-arm Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Diseases
Lead sponsor: Hangzhou Wei Qiang Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: procedure success rate
timeFrame: during the procedure
Secondary outcomes:
measure: the steerable catheter compliance during the procedure of catheter access into the target vascular
timeFrame: during the procedure
measure: the steerable catheter directivity during the procedure of catheter access into the target vascular
timeFrame: during the procedure
measure: the steerable catheter visibility under the X-ray during the procedure of catheter access into the target vascular
timeFrame: during the procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Weiguo Fu, MD
role: PRINCIPAL_INVESTIGATOR
References: