First-in-man Study of Titanium-Nitride Coated Woven-nitinol Peripheral Arterial Stent
NCT ID: NCT02499510
Last Updated: 2019-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2015-10-31
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GoldenFlow stent
Titanium nitrite coated woven nitinol stent
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Symptomatic leg ischemia (Rutherford class 2 to 4)
3. Ankle Brachial Index \<0.9
4. De novo femoropopliteal stenosis (≥70%) or occlusion
5. Reference diameter 4 and 7mm
6. Lesion length 4 to 15cm
7. At least one patent (\<50% stenosis) infrapopliteal run-off vessel
8. The lesion(s) can be successfully crossed with a guidewire and dilated
9. Patients with bilateral femoropopliteal disease is eligible for enrollment into the study
\- Staged contralateral limb procedure can be performed \>30 days after index procedure
10. Able to provide written informed consent and willing to comply with specified follow-up evaluation schedule
Exclusion Criteria
2. Previous bypass surgery or stenting in target vessel
3. Untreated aortoiliac or common femoral artery inflow disease \>50%
4. Intervention of ipsilateral lesions during the index procedure or staged intervention within 30 days after index procedure
18 Years
ALL
No
Sponsors
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Lifetech Scientific (Shenzhen) Co., Ltd.
INDUSTRY
Chinese University of Hong Kong
OTHER
Responsible Party
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Professor Bryan Ping Yen YAN
Professor
Principal Investigators
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Bryan Ping Yen Yan
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Countries
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References
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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.
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.
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.
Capek P, McLean GK, Berkowitz HD. Femoropopliteal angioplasty. Factors influencing long-term success. Circulation. 1991 Feb;83(2 Suppl):I70-80.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Not_applicable
Identifier Type: -
Identifier Source: org_study_id
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