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China Made Sirolimus Eluting Stent for Intermediate Lesion

NCT01375296 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2011-06-17

No results posted yet for this study

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.

Conditions

Interventions

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

routine medicine

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

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-10-31
Completion
2011-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01375296 on ClinicalTrials.gov