Firebird2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent Registry Trial

Launched by SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD. · Mar 24, 2009

Keywords

ClinConnect Summary

\[Definition and management of adverse event\] 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.

\[Classificat...

Gender

ALL

Eligibility 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