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Peripheral Arterial DiseaseNCT02499510

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

A study testing GoldenFlow Stent in people with Peripheral Arterial Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
GoldenFlow Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteHong Kong
Study dates
Oct 2015to May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years
  • Symptomatic leg ischemia (Rutherford class 2 to 4)
  • Ankle Brachial Index <0.9
  • De novo femoropopliteal stenosis (≥70%) or occlusion
  • Reference diameter 4 and 7mm
  • Lesion length 4 to 15cm
Show all 11Show fewer
  • At least one patent (<50% stenosis) infrapopliteal run-off vessel
  • The lesion(s) can be successfully crossed with a guidewire and dilated
  • Patients with bilateral femoropopliteal disease is eligible for enrollment into the study
  • Staged contralateral limb procedure can be performed >30 days after index procedure
  • Able to provide written informed consent and willing to comply with specified follow-up evaluation schedule

Who cannot join

  • Tissue loss or gangrene (Rutherford class 5 and 6)
  • Previous bypass surgery or stenting in target vessel
  • Untreated aortoiliac or common femoral artery inflow disease >50%
  • Intervention of ipsilateral lesions during the index procedure or staged intervention within 30 days after index procedure

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Prince of Wales Hospital

    Shatin, New Territories

Other trials in Hong Kong

About this study

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

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.

Read the detailed description

Endovascular treatment in femoropopliteal segment is the most challenging area due to restenosis and stent fracture after endovascular treatment. The titanium-nitride coated woven-nitinol peripheral arterial stent system (GoldenFlow, Lifetech Science, Shenzhen, China) is designed to have superior radial strength, flexibility and durability to withstand the compression, torsion, bending, lengthening and shortening found in femoropopliteal disease. Compared to another commercially available woven-nitinol stent, the GoldenFlow stent has the potential advantage to be repositionable and is less likely to lengthen during deployment. This is a first-in-man study is to evaluate the safety and efficacy of GoldenFlow woven-nitinol stent for intraluminal treatment of peripheral vascular disease in de-novo femoropopliteal lesions.

Being tested
GoldenFlow Stent
Keywords
femoropopliteal disease, restenosis
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GoldenFlow StentDevice

    Also called Titanium-nitride coated GoldenFlow woven-nitinol 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.

Study groups in NCT02499510
Study groupRoleWhat they receive
GoldenFlow stentExperimentalTitanium nitrite coated woven nitinol stent
Receives: Device: GoldenFlow Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-stent binary restenosis of the treated segment

    Determined by Duplex ultrasound

    Measured: at 6 month

Secondary outcomes (4)

  1. Technical Success

    defined as residual diameter stenosis <30%

    Measured: intraoperation

  2. Safety Outcomes as assessed by composite of death, index limb amputation and ischemic driven target vessel revacularization

    Composite of death, index limb amputation and ischemic driven target vessel revacularization at 30 days

    Measured: 30 days

  3. Clinically driven target vessel revascularization

    Measured: 6 months

  4. Stent fracture

    defined by plain x-ray

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionNov 2017
  4. Study completionMay 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02499510
Sponsor's protocol ID
Not_applicable
Status last verified
Jul 2019
First submitted
11 May 2015
Last updated
29 Jul 2019
Results posted
No
Data monitoring committee
No

Publications

  • Dormandy JA, Rutherford RB. Management of peripheral arterial disease (PAD). TASC Working Group. TransAtlantic Inter-Society Consensus (TASC). J Vasc Surg. 2000 Jan;31(1 Pt 2):S1-S296. No abstract available.

    PubMed 10666287

  • Johnston KW. Femoral and popliteal arteries: reanalysis of results of balloon angioplasty. Radiology. 1992 Jun;183(3):767-71. doi: 10.1148/radiology.183.3.1294068.

    PubMed 1294068

  • Minar E, Pokrajac B, Maca T, Ahmadi R, Fellner C, Mittlbock M, Seitz W, Wolfram R, Potter R. Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty : results of a prospective randomized study. Circulation. 2000 Nov 28;102(22):2694-9. doi: 10.1161/01.cir.102.22.2694.

    PubMed 11094034

  • Capek P, McLean GK, Berkowitz HD. Femoropopliteal angioplasty. Factors influencing long-term success. Circulation. 1991 Feb;83(2 Suppl):I70-80.

    PubMed 1825050

  • Henry M, Amor M, Beyar R, Henry I, Porte JM, Mentre B, Tricoche O, Ethevenot G. Clinical experience with a new nitinol self-expanding stent in peripheral arteries. J Endovasc Surg. 1996 Nov;3(4):369-79. doi: 10.1583/1074-6218(1996)0032.0.CO;2.

    PubMed 8959493

  • Cejna M, Thurnher S, Illiasch H, Horvath W, Waldenberger P, Hornik K, Lammer J. PTA versus Palmaz stent placement in femoropopliteal artery obstructions: a multicenter prospective randomized study. J Vasc Interv Radiol. 2001 Jan;12(1):23-31. doi: 10.1016/s1051-0443(07)61397-9.

    PubMed 11200349

  • Vroegindeweij D, Vos LD, Tielbeek AV, Buth J, vd Bosch HC. Balloon angioplasty combined with primary stenting versus balloon angioplasty alone in femoropopliteal obstructions: A comparative randomized study. Cardiovasc Intervent Radiol. 1997 Nov-Dec;20(6):420-5. doi: 10.1007/s002709900186.

    PubMed 9354709

  • Grimm J, Muller-Hulsbeck S, Jahnke T, Hilbert C, Brossmann J, Heller M. Randomized study to compare PTA alone versus PTA with Palmaz stent placement for femoropopliteal lesions. J Vasc Interv Radiol. 2001 Aug;12(8):935-42. doi: 10.1016/s1051-0443(07)61572-3.

    PubMed 11487673

  • Zdanowski Z, Albrechtsson U, Lundin A, Jonung T, Ribbe E, Thorne J, Norgren L. Percutaneous transluminal angioplasty with or without stenting for femoropopliteal occlusions? A randomized controlled study. Int Angiol. 1999 Dec;18(4):251-5.

    PubMed 10811511

  • Becquemin JP, Favre JP, Marzelle J, Nemoz C, Corsin C, Leizorovicz A. Systematic versus selective stent placement after superficial femoral artery balloon angioplasty: a multicenter prospective randomized study. J Vasc Surg. 2003 Mar;37(3):487-94. doi: 10.1067/mva.2003.155.

    PubMed 12618680

  • Schillinger M, Minar E. Endovascular stent implantation for treatment of peripheral artery disease. Eur J Clin Invest. 2007 Mar;37(3):165-70. doi: 10.1111/j.1365-2362.2007.01774.x.

    PubMed 17359483

  • Tetteroo E, van der Graaf Y, Bosch JL, van Engelen AD, Hunink MG, Eikelboom BC, Mali WP. Randomised comparison of primary stent placement versus primary angioplasty followed by selective stent placement in patients with iliac-artery occlusive disease. Dutch Iliac Stent Trial Study Group. Lancet. 1998 Apr 18;351(9110):1153-9. doi: 10.1016/s0140-6736(97)09508-1.

    PubMed 9643685

Questions about this trial

What is this clinical trial studying?

A study testing GoldenFlow Stent in people with Peripheral Arterial Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-stent binary restenosis of the treated segment (time frame: at 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02499510, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.

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