The Real-world Firebird 2 Versus Cypher Sirolimus-eluting Stent in Treating Patients With Coronary Artery Disease

NCT01328730 | Withdrawn Phase 4 DMC

• 1 other identifier: RJH20110331
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Stenosis

Keywords

significant stenosis (>70% of lumen stenosis); epicardial coronary arteries.

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• target vessel failure

  1, and 2 years after index procedure

Study Arms (2)

Firebird 2 stent group

EXPERIMENTAL

patients who were implated with Firebird 2 SES

Device: Firebird 2 SES

Cypher Stent Group

ACTIVE COMPARATOR

patients who were implanted with Cypher SES

Device: Cypher SES

Interventions

Firebird 2 SES DEVICE

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.

Firebird 2 stent group

Cypher SES DEVICE

The Cypher SES is based on the 316L platform with Controlled-release, nonresorbable, elastomeric polymer coating.

Cypher Stent Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 5, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2013
• Last Updated: June 14, 2011

Record last verified: 2011-03

Locations

CN (1)