China Made Sirolimus Eluting Stent for Intermediate Lesion

NCT ID: NCT01375296

Last Updated: 2011-06-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-11-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

China-made SES (Firebird 2 and Excel)

Intervention Type: DEVICE

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

Group Type: OTHER

routine medicine

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: DEVICE

routine medicine

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ruijin hospital, shanghai jiao tong university school of medicine

Locations

ruijin hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ruiyan Zhang, MD

Role: CONTACT

zhangruiyan@263.net

862164370045 ext. 665215

Facility Contacts

Ruiyan Zhang, MD

Role: primary

zhangruiyan@263.net

862164370045 ext. 665215

Other Identifiers

RJH20100918

Identifier Type: -

Identifier Source: org_study_id