Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease (FESTA)

Shanghai Jiao Tong University School of Medicine

Status and phase

Unknown

Phase 4

Conditions

Coronary Artery Disease

Treatments

Device: Firebird 2 sirolimus-eluting stent

Device: Excel sirolimus-eluting stent

Study type

Interventional

Funder types

Other

Identifiers

NCT01373632

20110611

Details and patient eligibility

About

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 Excel SES (JW Medical, Shandong, China, MA) with biodegradable polymer has been proved by several 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) with durable polymer, comparing with Excel SES.

Enrollment

570 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age > 18 years
male or un-pregnant 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