- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00868829
Firebird2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent Registry Trial (FOCUS)
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Caihong Wang
- Phone Number: 838 68-10-84094918
- Email: wch@ccheart.com.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China
- Recruiting
- Zhongshan Hospital
-
Contact:
- Caihong Wang
- Email: wch@ccheart.com.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age≧18 years
- Patient being suitable candidate for the implantation of drug-eluting stent at physician's discretion
- Patient with multivessel disease who receive only Firebird2 Stent
- Patient agrees to provide informed consent to follow the clinical trial protocol, including medications, and baseline and follow-up visits and procedures.
Exclusion Criteria:
- Patient not being suitable candidate for the implantation of drug-eluting stent at physician's discretion
- Patient with multivessel disease who receive other type of stents instead of only Firebird2 Stent
- Patient who receive other PCI interventions, such as rotablation, directional coronary atherectomy (DCA), TEC, CRA, laser angioplasty, etc.), in addition to PTCA and stenting
- Patient refuses to provide informed consent
- Patient who are not able to follow the clinical trial protocol, including medications, and baseline and follow-up visits and procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Firebird2
|
For the patient participated, only Firebird2 Stent will be implanted.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
rate of major adverse cardiac events
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Junbo Ge, Shanghai Zhongshan Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Trace Elements
- Micronutrients
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
- Chromium
Other Study ID Numbers
- MPMFB22009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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