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

Evaluate the Safety and Efficacy of a Steerable Catheter in the Treatment of Vascular Interventional Access : a Prospective, Muti-center, Single-arm 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 of subjects intraoperative and postoperative (discharge) before and after 30 days .

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Diseases
• Intervention / Treatment: Device: steerable catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: steerable catheter; to study the safety and efficacy of a steerable catheter in the treatment of peripheral vascular disease	Device: steerable catheter; peripheral vascular disease

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hangzhou Wei Qiang Medical Technology Co., Ltd.
• Investigators: Principal Investigator: Weiguo Fu, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 11, 2017
• Primary Completion (ACTUAL): November 27, 2017
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 16, 2017
• First Posted (ACTUAL): June 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: LT002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No