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

Peripheral Vascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03191500
• Other study ID #: LT002
• Status: Completed
• Phase: N/A
• First received: June 13, 2017
• Last updated: March 20, 2018
• Start date: July 11, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2018
• Source: Hangzhou Wei Qiang Medical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 31, 2017
• Est. primary completion date: November 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• steerable catheter
peripheral vascular disease

Locations

Country	Name	City	State
China	Zhongshan hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Wei Qiang Medical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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