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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02499510
• Other study ID #: Not_applicable
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: May 2018

Study information

• Verified date: July 2019
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin	New Territories

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Lifetech Scientific (Shenzhen) Co., Ltd.

Country where clinical trial is conducted

Hong Kong, 

References & Publications (12)

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. — View Citation

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

Grimm J, Müller-Hülsbeck 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. — View 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. — View Citation

Johnston KW. Femoral and popliteal arteries: reanalysis of results of balloon angioplasty. Radiology. 1992 Jun;183(3):767-71. — View Citation

Minar E, Pokrajac B, Maca T, Ahmadi R, Fellner C, Mittlböck M, Seitz W, Wolfram R, Pötter R. Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty : results of a prospective randomized study. Circulation. 2000 Nov 28;102(22):2694-9. — View Citation

Schillinger M, Minar E. Endovascular stent implantation for treatment of peripheral artery disease. Eur J Clin Invest. 2007 Mar;37(3):165-70. — View 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. — View 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. — View Citation

Zdanowski Z, Albrechtsson U, Lundin A, Jonung T, Ribbe E, Thörne 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent binary restenosis of the treated segment	Determined by Duplex ultrasound	at 6 month
Secondary	Technical Success	defined as residual diameter stenosis <30%	intraoperation
Secondary	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	30 days
Secondary	Clinically driven target vessel revascularization		6 months
Secondary	Stent fracture	defined by plain x-ray	6 months