CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5 enrolled
Drug / intervention
GoldenFlow Stentdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02499510
NCT02499510N/ACompleted

First-in-man Study to Assess Efficacy and Safety of a Novel Titanium-Nitride Coated Woven-nitinol Peripheral Arterial Stent

Chinese University of Hong Kong·interventional·Posted Jul 16, 2015·Updated Jul 29, 2019

In Brief

A clinical study evaluating GoldenFlow Stent for Peripheral Arterial Disease. Completed, enrolled 5 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHong Kong

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 16, 2015
Enrollment StartOct 1, 2015
Primary CompletionNov 1, 2017
Study CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.0 years ago

Interventions

GoldenFlow Stentdevice

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.