China Made Sirolimus Eluting Stent for Intermediate Lesion (SESIL)

June 16, 2011 updated by: Shanghai Jiao Tong University School of Medicine

China Made Sirolimus Eluting Stent for Treatment of Coronary Intermediate Lesion

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SES
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).
Device: China-made SES (Firebird 2 and Excel)
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).
Other: medicine
Other: routine medicine
patients with coronary 50-70% narrowing treated with routine medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
target vessel failure
Time Frame: 12 months
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]).
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

November 1, 2011

Study Registration Dates

First Submitted

April 1, 2011

First Submitted That Met QC Criteria

June 16, 2011

First Posted (Estimate)

June 17, 2011

Study Record Updates

Last Update Posted (Estimate)

June 17, 2011

Last Update Submitted That Met QC Criteria

June 16, 2011

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJH20100918

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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