Safety and Efficacy Registry of Yinyi Stent (SERY-II) | NCT01373658

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

NCT01373658

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Jun 15, 2011Estimated

Enrollment

200Estimated

Phase

Phase 2Phase 3

Conditions

Coronary Artery Disease

Interventions

Yinyi stent

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Oct 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Apr 1, 2011

First Submission Date that Met QC Criteria

Jun 13, 2011

First Posted Date

Jun 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2011

Last Update Posted Date

Jun 15, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Yinyi stent	Experimental		Device: Yinyi stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Yinyi stent	Device	subjects with Yinyi stent implantation	Yinyi stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	12 months

Secondary Outcomes

Measure	Description	Time Frame
major adverse cardiac events	including cardiac death, re-infarction, and target vessel revascularization	12 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ruiyan Zhang, MD	Contact	862164370045	665215	zhangruiyan@263.net

Overall Officials

Name	Affiliation	Role
Ruiyan Zhang, MD	Ruijin Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ruijin hospital, Shanghai Jiao Tong University, School of Medicine	Recruiting	Shanghai	Shanghai Municipality	200025	China

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided