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Firebird2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent Registry Trial (FOCUS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Shanghai MicroPort Medical (Group) Co., Ltd..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00868829
First Posted: March 25, 2009
Last Update Posted: August 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shanghai MicroPort Medical (Group) Co., Ltd.
  Purpose
The experimental design is a multi-center, prospective, non-controlled, non-randomized, single-arm clinical registry trial. The study will enroll 5,000 patients who receive the Firebird2TM Cobalt-ChromiumAlloyed Sirolimus-Eluting Stent implantation. For patient with multivessel disease, only Firebird 2TM Stent will be implanted. The enrollment of patients will take about 4 months. Clinical follow-up will be at 30 day, 6 month, 12 month, 24 month and 36 month. Patients withdrawing the study due to any reasons will not be replaced.

Condition Intervention
Coronary Heart Disease Device: Firebird2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Firebird2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent Registry Trial

Resource links provided by NLM:


Further study details as provided by Shanghai MicroPort Medical (Group) Co., Ltd.:

Primary Outcome Measures:
  • rate of major adverse cardiac events [ Time Frame: 12 months ]

Estimated Enrollment: 5000
Study Start Date: April 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Firebird2 Device: Firebird2
For the patient participated, only Firebird2 Stent will be implanted.
Other Name: Firebird2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent

Detailed Description:

[Definition and management of adverse event] Adverse event refers to any undesirable clinical event. It may be caused by devices, rapamycin, procedure related complications, or the adjunctive medications (such as aspirin, clopidogrel, ticlopidine, or other anti-platelet agent) used in this study. Self report of adverse events by patients should be encouraged. Patients have a right to inquire any information on adverse event at any time of the study. If an adverse event is confirmed, the investigator should collect all related information and complete the Adverse Event Form.

[Classification of adverse events severity] Mild: Mild adverse event refers to clinical event not interfering patient's daily activities.

Moderate: Moderate adverse event refers to clinical event affecting patient's daily activities.

Serious: Serious adverse event refers to clinical event results in patient's inability to undertake daily activity.

[Management of adverse event] All adverse events occurring during the study period should be documented on Adverse Event Forms. Investigators should provide appropriate treatment for all adverse events and follow up the patient until symptom(s) disappear or remain stable

[Documents Recordkeeping] All CRFs and their other original supporting files (such as the informed consent, the lab report, the process records, medical history, the results of physical examinations and diagnosis, the diagnosis, procedure dates and the records regarding equipment management) must be set up in a secure central location by a research site staff and maintained for at least 2 years upon the notification on the termination or completion of the trial issued by MicroPort Medical.

In case the person in charge of keeping these files cannot keep the trial records continuously due to retirement, transferring or any other reason, the recordkeeping should be handed over to another person who is able to accept this task, and a written notification with the successor's name and address should be sent to MicroPort and the Ethics Committee.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age≧18 years
  2. Patient being suitable candidate for the implantation of drug-eluting stent at physician's discretion
  3. Patient with multivessel disease who receive only Firebird2 Stent
  4. Patient agrees to provide informed consent to follow the clinical trial protocol, including medications, and baseline and follow-up visits and procedures.

Exclusion Criteria:

  1. Patient not being suitable candidate for the implantation of drug-eluting stent at physician's discretion
  2. Patient with multivessel disease who receive other type of stents instead of only Firebird2 Stent
  3. Patient who receive other PCI interventions, such as rotablation, directional coronary atherectomy (DCA), TEC, CRA, laser angioplasty, etc.), in addition to PTCA and stenting
  4. Patient refuses to provide informed consent
  5. Patient who are not able to follow the clinical trial protocol, including medications, and baseline and follow-up visits and procedures
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868829


Contacts
Contact: Caihong Wang 68-10-84094918 ext 838 wch@ccheart.com.cn

Locations
China, Shanghai
Zhongshan Hospital Recruiting
Shanghai, Shanghai, China
Contact: Caihong Wang       wch@ccheart.com.cn   
Sponsors and Collaborators
Shanghai MicroPort Medical (Group) Co., Ltd.
Investigators
Principal Investigator: Junbo Ge Shanghai Zhongshan Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Junbo Ge, Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT00868829     History of Changes
Other Study ID Numbers: MPMFB22009
First Submitted: March 23, 2009
First Posted: March 25, 2009
Last Update Posted: August 10, 2011
Last Verified: August 2011

Keywords provided by Shanghai MicroPort Medical (Group) Co., Ltd.:
Stent
FireBird2
Coronary Heart Disease

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Sirolimus
Everolimus
Chromium
Cobalt
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances