NCT02499510

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2019

Enrollment Period

2.1 years

First QC Date

May 11, 2015

Last Update Submit

July 26, 2019

Conditions

Peripheral Arterial Disease

Keywords

femoropopliteal diseaserestenosis

Outcome Measures

Primary Outcomes (1)

  • In-stent binary restenosis of the treated segment

    Determined by Duplex ultrasound

    at 6 month

Secondary Outcomes (4)

  • Technical Success

    intraoperation

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

    30 days

  • Clinically driven target vessel revascularization

    6 months

  • Stent fracture

    6 months

Study Arms (1)

GoldenFlow stent

EXPERIMENTAL

Titanium nitrite coated woven nitinol stent

Device: GoldenFlow Stent

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.

Also known as: Titanium-nitride coated GoldenFlow woven-nitinol stent
GoldenFlow stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

Related Publications (12)

  • 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.

    PMID: 10666287BACKGROUND

  • 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.

    PMID: 1294068BACKGROUND

  • 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.

    PMID: 11094034BACKGROUND

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

    PMID: 1825050BACKGROUND

  • 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.

    PMID: 8959493BACKGROUND

  • 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.

    PMID: 11200349BACKGROUND

  • 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.

    PMID: 9354709BACKGROUND

  • 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.

    PMID: 11487673BACKGROUND

  • 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.

    PMID: 10811511BACKGROUND

  • 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.

    PMID: 12618680BACKGROUND

  • 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.

    PMID: 17359483BACKGROUND

  • 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.

    PMID: 9643685BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Bryan Ping Yen Yan

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 11, 2015

First Posted

July 16, 2015

Study Start

October 1, 2015

Primary Completion

November 1, 2017

Study Completion

May 1, 2018

Last Updated

July 29, 2019

Record last verified: 2019-07

Locations

HK(1)