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Completed

NCT Number: NCT03191500

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

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 .

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Key information

Conditions

Peripheral Vascular Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

steerable catheter

Device

peripheral vascular disease

Primary outcomes

  1. procedure success rate

    Time frame: during the procedure

    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.

Secondary outcomes

  1. the steerable catheter compliance during the procedure of catheter access into the target vascular

    Time frame: during the procedure

    evaluate with excellent, good , general, poor four levels (according to surgeons experience to score)

  2. the steerable catheter directivity during the procedure of catheter access into the target vascular

    Time frame: during the procedure

    evaluate with excellent, good , general, poor four levels (according to surgeons experience to score)

  3. the steerable catheter visibility under the X-ray during the procedure of catheter access into the target vascular

    Time frame: during the procedure

    evaluate with excellent, good , general, poor four levels (according to surgeons experience to score)

Sponsors and collaborators

Lead sponsor

Hangzhou Wei Qiang Medical Technology Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 19, 2017
Registry last updated
Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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