Clinical trial NCT02499510: First-in-man Study of Titanium-Nitride Coated Woven-nitinol Peripheral Arterial Stent
Official title: First-in-man Study to Assess Efficacy and Safety of a Novel Titanium-Nitride Coated Woven-nitinol Peripheral Arterial Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: femoropopliteal disease
restenosis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Lifetech Scientific (Shenzhen) Co., Ltd.
First posted: 2015-07-16
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
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:

1. Tissue loss or gangrene (Rutherford class 5 and 6)
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

Primary outcomes:
measure: In-stent binary restenosis of the treated segment
timeFrame: at 6 month
Secondary outcomes:
measure: Technical Success
timeFrame: intraoperation
measure: Safety Outcomes as assessed by composite of death, index limb amputation and ischemic driven target vessel revacularization
timeFrame: 30 days
measure: Clinically driven target vessel revascularization
timeFrame: 6 months
measure: Stent fracture
timeFrame: 6 months
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: New Territories
Study officials:
affiliation: Chinese University of Hong Kong
name: Bryan Ping Yen Yan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Capek P, McLean GK, Berkowitz HD. Femoropopliteal angioplasty. Factors influencing long-term success. Circulation. 1991 Feb;83(2 Suppl):I70-80.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.