NCT01373632

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
570

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

June 15, 2011

Status Verified

June 1, 2011

Enrollment Period

1 year

First QC Date

June 13, 2011

Last Update Submit

June 14, 2011

Conditions

Coronary Artery Disease

Keywords

significant stenosis (>70% of lumen stenosis)epicardial coronary arteriesclinical ischemic

Outcome Measures

Primary Outcomes (1)

  • in-stent late lumen loss at 9 months' angiographic follow-up

    patients are planned to receive angiographic follow-up at 9 months after index procedure, and in-stent late lumen loss will be analyzed

    9 months

Secondary Outcomes (1)

  • target vessel failure

    2 years after index procedure

Study Arms (2)

Firebird 2 stent group

EXPERIMENTAL

the patients who receive Firebird 2 stent

Device: Firebird 2 sirolimus-eluting stent

Excel stent group

ACTIVE COMPARATOR

the patients who receive Excel stent

Device: Excel sirolimus-eluting stent

Interventions

Firebird 2 sirolimus-eluting stentDEVICE

the Firebird 2 sirolimus-eluting stent is a SES with durable polymer based on Co-Cr stent platform

Firebird 2 stent group
Excel sirolimus-eluting stentDEVICE

the Excel sirolimus-eluting stent is a stent with biodegradable polymer (PLA) based on stainless steel (316L) stent platform

Excel stent group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (2)

  • Zhang Q, Xu B, Yang YJ, Zhang RY, Li JP, Qiao SB, Zhang JS, Hu J, Qin XW, Hong T, Chen JL, Huo Y, Shen WF, Gao RL. Sirolimus-eluting cobalt alloyed stents in treating patients with coronary artery disease: six-month angiographic and one-year clinical follow-up result. A prospective, historically controlled, multi-center clinical study. Chin Med J (Engl). 2007 Apr 5;120(7):533-8.

    PMID: 17442198BACKGROUND

  • Han Y, Jing Q, Chen X, Wang S, Ma Y, Liu H, Luan B, Wang G, Li Y, Wang Z, Wang D, Xu B, Gao R. Long-term clinical, angiographic, and intravascular ultrasound outcomes of biodegradable polymer-coated sirolimus-eluting stents. Catheter Cardiovasc Interv. 2008 Aug 1;72(2):177-83. doi: 10.1002/ccd.21600.

    PMID: 18655114BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular 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

June 13, 2011

First Posted

June 15, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Study Completion

September 1, 2013

Last Updated

June 15, 2011

Record last verified: 2011-06

Locations

CN(1)