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

Primary Purpose

Peripheral Vascular Diseases

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

steerable catheter

About this trial

This is an interventional treatment trial for Peripheral Vascular Diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Zhongshan hospital Fudan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

steerable catheter

Arm Description

to study the safety and efficacy of a steerable catheter in the treatment of peripheral vascular disease

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

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)

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)

Full Information

NCT ID

NCT03191500

First Posted

June 13, 2017

Last Updated

March 20, 2018

Sponsor

Hangzhou Wei Qiang Medical Technology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03191500

Brief Title

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

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

July 11, 2017 (Actual)

Primary Completion Date

November 27, 2017 (Actual)

Study Completion Date

December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hangzhou Wei Qiang Medical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Vascular Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

steerable catheter

Arm Type

Experimental

Arm Description

to study the safety and efficacy of a steerable catheter in the treatment of peripheral vascular disease

Intervention Type

Device

Intervention Name(s)

steerable catheter

Intervention Description

peripheral vascular disease

Primary Outcome Measure Information:

Title

procedure success rate

Description

Time Frame

during the procedure

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

during the procedure

Title

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

Description

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

Time Frame

during the procedure

Title

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

Description

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

Time Frame

during the procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Weiguo Fu, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan hospital Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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