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

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: GoldenFlow Stent

• Registration Number: NCT02499510
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-16
• Study Start: 2015-10
• Primary Completion: 2017-11
• Study Completion: 2018-05
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-26
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GoldenFlow stent	GoldenFlow Stent	Titanium nitrite coated woven nitinol stent

Primary Outcome Measures

Name	Time	Method
In-stent binary restenosis of the treated segment	at 6 month	Determined by Duplex ultrasound

Secondary Outcome Measures

Name	Time	Method
Clinically driven target vessel revascularization	6 months
Stent fracture	6 months	defined by plain x-ray
Technical Success	intraoperation	defined as residual diameter stenosis \<30%
Safety Outcomes as assessed by composite of death, index limb amputation and ischemic driven target vessel revacularization	30 days	Composite of death, index limb amputation and ischemic driven target vessel revacularization at 30 days

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, New Territories, Hong Kong