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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01328730
Other study ID # RJH20110331
Secondary ID
Status Withdrawn
Phase Phase 4
First received April 1, 2011
Last updated June 13, 2011
Start date April 2011
Est. completion date June 2013

Study information

Verified date March 2011
Source Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority Institution of Cardiovascular Disease, Shanghai Jiaotong University School of Medicine: China
Study type Interventional

Clinical Trial Summary

Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating patients with coronary artery disease (CAD). The efficacy and safety of Cypher SES (Cordis, MA) has been proved by several randomized clinical trials. Here the investigators design a prospective, multicenter, randomized clinical study in purpose of identifying the non-inferiority in the efficacy and safety in treating CAD patients by Firebird 2 SES (Microport, Shanghai), comparing with Cypher SES.


Recruitment information / eligibility

Status Withdrawn
Enrollment 430
Est. completion date June 2013
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age > 18 years

- male or un-preganant female

- stenosis > 70% in one of major the epicardial coronary arteries

- no contra-indications of stent implantation

- singed the informed consent

Exclusion Criteria:

- acute myocardial infarction within one week

- have contra-indications of stent implantation or can not tolerate dual antiplatelet therapy

- no history of stent implantation within last one-year

- received other brand coronary stent during index procedure

- with no achievement of informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
Firebird 2 SES
The FIREBIRD2™ Rapamycin-Eluting CoCr Coronary Stent is the second generation DES of MicroPort, which based on the new cobalt chromium alloy stent platform. It uses polyolefin polymer, which makes the coating property very remarkable.
Cypher SES
The Cypher SES is based on the 316L platform with Controlled-release, nonresorbable, elastomeric polymer coating.

Locations

Country Name City State
China Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary in-stent late lumen loss at 9 months' angiographic follow-up Late luminal loss was defined as the difference between the minimal luminal diameter immediately after the placement of the stent and the minimal luminal diameter at 9 months 9 months Yes
Secondary target vessel failure defined as the occurrence of any of the following within 1 and 2 years after the index procedure: death from cardiac causes, Q-wave or non-Q-wave myocardial infarction, or revascularizationof the target vessel (emergency or elective coronaryartery bypass grafting [CABG] or repeated percutaneous transluminal coronary angioplasty [PTCA]). 1, and 2 years after index procedure Yes
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