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

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

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.

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.

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