Safety and Efficacy Registry of Yinyi Stent (SERY-II)

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Coronary Artery Disease

Treatments: Device: Yinyi stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01373658

RJH20100910

Details and patient eligibility

About

Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel from a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd) may prevent these complications.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18-80 years old
• both gender
• native coronary lesion
• narrowing > 70%
• vessel size 2.5-4.0 in diameter

Exclusion criteria

• without informed consent,
• ST elevation myocardial infarction within 7 days,
• patient with ≤ 70% coronary narrowing at target lesion,
• left main lesion,
• multivessel narrowing need more than 3 stent implantations,
• by-pass graft,
• abnormal liver function before randomization,
• active hepatitis or muscular disease,
• impaired renal function with serum creatinine level > 3mg/dl,
• impaired left ventricular function with LVEF < 30%,
• participate in other studies.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Yinyi stent

Experimental group

Treatment:

Device: Yinyi stent