China Made Sirolimus Eluting Stent for Intermediate Lesion (SESIL)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01375296
First received: April 1, 2011
Last updated: June 16, 2011
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: China-made SES (Firebird 2 and Excel)
Other: routine medicine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: China Made Sirolimus Eluting Stent for Treatment of Coronary Intermediate Lesion

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • target vessel failure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    including cardiac death, re-infarction and target vessel revascularization.


Estimated Enrollment: 600
Study Start Date: May 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
medicine Other: routine medicine
patients with coronary 50-70% narrowing treated with routine medicine

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375296

Contacts
Contact: Ruiyan Zhang, MD 862164370045 ext 665215 zhangruiyan@263.net

Locations
China, Shanghai
ruijin hospital, Shanghai Jiao Tong University, School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Ruiyan Zhang, MD    862164370045 ext 665215    zhangruiyan@263.net   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
  More Information

No publications provided

Responsible Party: Weifeng Shen, Ruijin hospital, shanghai jiao tong university school of medicine
ClinicalTrials.gov Identifier: NCT01375296     History of Changes
Other Study ID Numbers: RJH20100918
Study First Received: April 1, 2011
Last Updated: June 16, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014