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China Made Sirolimus Eluting Stent for Intermediate Lesion (SESIL)

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

China-made SES (Firebird 2 and Excel)

routine medicine

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 50-70%
vessel size 2.5-4.0 in diameter

Exclusion Criteria:

without informed consent,
ST elevation myocardial infarction within 7 days,
left main lesion,
by-pass graft,
restenosis
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 2

Arm Type

Experimental

Other

Arm Label

SES

medicine

Arm Description

including two types of China-made SES, i.e. Firebird 2 (cobalt-alloy platform with durable polymer coating sirolimus-eluting stent) and Excel (stainless steel platform with biodegradable polymer coating sirolimus-eluting stent).

Outcomes

Primary Outcome Measures

target vessel failure

defined as the occurrence of any of the following within 12 months after the index procedure: death from cardiac causes, Q-wave or non-Q-wave myocardial infarction, or revascularization of the target vessel (emergency or elective coronaryartery bypass grafting [CABG] or repeated percutaneous transluminal coronary angioplasty [PTCA]).

Secondary Outcome Measures

major adverse cardiac events

including cardiac death, re-infarction and target vessel revascularization.

Full Information

NCT ID

NCT01375296

First Posted

April 1, 2011

Last Updated

June 16, 2011

Sponsor

Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01375296

Brief Title

China Made Sirolimus Eluting Stent for Intermediate Lesion

Acronym

SESIL

Official Title

China Made Sirolimus Eluting Stent for Treatment of Coronary Intermediate Lesion

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Unknown status

Study Start Date

May 2009 (undefined)

Primary Completion Date

October 2011 (Anticipated)

Study Completion Date

November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Shanghai Jiao Tong University School of Medicine

4. Oversight

5. Study Description

Brief Summary

Sirolimus-eluting stent (SES) has been proven to improve outcomes in patients with significant coronary artery diseae(> 70% lumen diameter narrowing). But, acute coronary syndrome may occur in those with intermediate lesions(50%-70% lumen diameter narrowing), and the effect of SES in these patients remains unclear. Here the investigators hypothesize that application of China-made SES may improve the clinical outcomes in these setting.

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

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SES

Arm Type

Experimental

Arm Description

Arm Title

medicine

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

China-made SES (Firebird 2 and Excel)

Intervention Description

patients with coronary 50-70% narrowing treated with China-made SES stent,i.e. Firebird 2 (cobalt-alloy platform with durable polymer coating sirolimus-eluting stent) and Excel (stainless steel platform with biodegradable polymer coating sirolimus-eluting stent).

Intervention Type

Other

Intervention Name(s)

routine medicine

Intervention Description

patients with coronary 50-70% narrowing treated with routine medicine

Primary Outcome Measure Information:

Title

target vessel failure

Description

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

Eligibility Criteria

Inclusion Criteria: age 18-80 years old both gender native coronary lesion narrowing 50-70% vessel size 2.5-4.0 in diameter Exclusion Criteria: without informed consent, ST elevation myocardial infarction within 7 days, left main lesion, by-pass graft, restenosis 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

zhangruiyan@263.net

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

zhangruiyan@263.net

12. IPD Sharing Statement

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China Made Sirolimus Eluting Stent for Intermediate Lesion

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