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First-in-man Study of Titanium-Nitride Coated Woven-nitinol Peripheral Arterial Stent

NCT02499510 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-07-29

No results posted yet for this study

Summary

The GoldenFlow (Lifetech Scientific, Shenzhen, China) is a novel woven-nitinol stent designed to have superior radial strength, flexibility and durability compared to standard nitinol stents for femoropopliteal lesions. This is a first-in-man study to evaluate the safety and efficacy of GoldenFlow woven-nitinol stent for intraluminal treatment of peripheral vascular disease in the femoropopliteal arteries.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

GoldenFlow Stent

The GoldenFlow stent (Lifetech Science, Shenzhen, China) is a TiN coated self-expanding stent consisting of interwoven nitinol wires braided in a closed cell design. Stents used in this study ranged from 4-12mm in diameter and 20-160mm in length.

Sponsors & Collaborators

  • Lifetech Scientific (Shenzhen) Co., Ltd.

    collaborator INDUSTRY

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Bryan Ping Yen Yan · Chinese University of Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-11-30
Completion
2018-05-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02499510 on ClinicalTrials.gov