Safety and Efficacy Registry of Yinyi Stent

NCT ID: NCT01373645

Last Updated: 2015-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1045 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-12-31

Brief Summary

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Yinyi stent

subjects with Yinyi stent implantation

Group Type: EXPERIMENTAL

Yinyi stent

Intervention Type: DEVICE

subjects with Yinyi stent implantation

Interventions

Yinyi stent

subjects with Yinyi stent implantation

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ruijin hospital, shanghai jiao tong university school of medicine

Locations

ruijin hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

References

Zhang RY, Zhang Q, Zhu JZ, Chen LL, Zhang CY, Zhou XC, Yuan Y, Zhong ZX, Li L, Qiu J, Wang W, Chen XM, Yang ZJ, Yan JC, Chen SL, Hou YQ, Wu YQ, Luo HM, Qiu JP, Zhu L, Wang Y, Fu GS, Wang JA, Ma KH, Yin YH, Zhang DF, Hu XS, Zhu GY, Shen WF; Safety and Efficacy Registry of Yinyi stent (SERY-I) Investigators. Safety and efficacy of polymer-free paclitaxel-eluting microporous stent in real-world practice: 1-year follow-up of the SERY-I registry. Chin Med J (Engl). 2011 Nov;124(21):3521-6. No abstract available.

Reference Type: RESULT

PMID: 22340171 (View on PubMed)

Other Identifiers

RJH20100909

Identifier Type: -

Identifier Source: org_study_id