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

NCT ID: NCT01373658

Last Updated: 2011-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Yinyi stent

Group Type EXPERIMENTAL

Yinyi stent

Intervention Type DEVICE

subjects with Yinyi stent implantation

Interventions

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Yinyi stent

subjects with Yinyi stent implantation

Intervention Type DEVICE

Eligibility Criteria

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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

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Ruijin hospital, shanghai jiao tong university school of medicine

Principal Investigators

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Ruiyan Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

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ruijin hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ruiyan Zhang, MD

Role: CONTACT

862164370045 ext. 665215

Facility Contacts

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Ruiyan Zhang, MD

Role: primary

862164370045 ext. 665215

Other Identifiers

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RJH20100910

Identifier Type: -

Identifier Source: org_study_id

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