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

NCT03191500 | Completed

• 1 other identifier: LT002
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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 .

Conditions

Peripheral Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  during the procedure

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

  during the procedure

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

  during the procedure

Study Arms (1)

steerable catheter

EXPERIMENTAL

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

Device: steerable catheter

Interventions

steerable catheter DEVICE

peripheral vascular disease

steerable catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hangzhou Wei Qiang Medical Technology Co., Ltd.: lead

Study Sites (1)

Zhongshan hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Weiguo Fu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 19, 2017
• Study Start: July 11, 2017
• Primary Completion: November 27, 2017
• Study Completion: December 31, 2017
• Last Updated: March 21, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)