CompletedNot Applicable

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

Hong Kong5 participantsStarted 2015-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥18 years
✓. Symptomatic leg ischemia (Rutherford class 2 to 4)
✓. Ankle Brachial Index \<0.9
✓. De novo femoropopliteal stenosis (≥70%) or occlusion
✓. Reference diameter 4 and 7mm
✓. Lesion length 4 to 15cm
✓. At least one patent (\<50% stenosis) infrapopliteal run-off vessel
✓. The lesion(s) can be successfully crossed with a guidewire and dilated

Exclusion criteria

✕. Tissue loss or gangrene (Rutherford class 5 and 6)
✕. Previous bypass surgery or stenting in target vessel
✕. Untreated aortoiliac or common femoral artery inflow disease \>50%
✕. Intervention of ipsilateral lesions during the index procedure or staged intervention within 30 days after index procedure

What they're measuring

In-stent binary restenosis of the treated segment

Timeframe: at 6 month

Trial details

NCT IDNCT02499510

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-11

View on ClinicalTrials.gov More Peripheral Arterial Disease trials