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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Yinyi stent
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • ruijin hospital, Shanghai Jiao Tong University, School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yinyi stent

Arm Description

Outcomes

Primary Outcome Measures

late lumen loss
Late luminal loss was defined as the difference between the minimal luminal diameter immediately after the placement of the stent and the minimal luminal diameter at 12-month angiographic follow-up.

Secondary Outcome Measures

major adverse cardiac events
including cardiac death, re-infarction, and target vessel revascularization

Full Information

First Posted
April 1, 2011
Last Updated
June 13, 2011
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01373658
Brief Title
Safety and Efficacy Registry of Yinyi Stent (SERY-II)
Acronym
SERY-II
Official Title
Safety and Efficacy Registry of Yinyi Polymer-free Paclitaxel-eluting Stent
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yinyi stent
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Yinyi stent
Intervention Description
subjects with Yinyi stent implantation
Primary Outcome Measure Information:
Title
late lumen loss
Description
Late luminal loss was defined as the difference between the minimal luminal diameter immediately after the placement of the stent and the minimal luminal diameter at 12-month angiographic follow-up.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
major adverse cardiac events
Description
including cardiac death, re-infarction, and target vessel revascularization
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruiyan Zhang, MD
Phone
862164370045
Ext
665215
Email
zhangruiyan@263.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruiyan Zhang, MD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
ruijin hospital, Shanghai Jiao Tong University, School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruiyan Zhang, MD
Phone
862164370045
Ext
665215
Email
zhangruiyan@263.net

12. IPD Sharing Statement

Learn more about this trial

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

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