A Registry To Evaluate Safety And Effectiveness Of Everolimus Drug Eluting Stent For Coronary Revascularization (SEEDS)
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|ClinicalTrials.gov Identifier: NCT01157455|
Recruitment Status : Unknown
Verified April 2010 by CCRF Consulting Co., Ltd..
Recruitment status was: Recruiting
First Posted : July 7, 2010
Last Update Posted : July 12, 2010
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Diseases||Procedure: Everolimus Drug Eluting Stent Drug: Aspirin Drug: Clopidogrel Drug: Heparin or Bivalirudin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1900 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial Program of a Medical Instrument Product|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||March 2012|
|Estimated Study Completion Date :||June 2013|
- Procedure: Everolimus Drug Eluting Stent
- XIENCE(TM) V EECSS
- XIENCE(TM) V stent system
- Drug: Aspirin
Orally take by 300mg per day at least within 24 hours before index procedure. Orally 100mg indefinitely after the procedure as a part of dual anti-platelet therapy
- Drug: Clopidogrel
A loading dose of 300mg must be given at least 6 hours prior to index procedure, or a loading dose of 75mg/d 72 hours prior to index procedure.
75mg daily for at least 12 months after the procedure as a part of dual anti-platelet therapy.
- Drug: Heparin or Bivalirudin
During procedure or in-hospital, Heparin 100u/kg or Bivalirudin may be given,or follow up the standard practice of each site.
- TVF [ Time Frame: 12 months post-index procedure. ]Ischemia-driven Target Vessel Failure (TVF) which is a composite of cardiac death, myocardial infarction (Q and non-Q wave) and target vessel revascularization (TVR),12 months post-index procedure.
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): NCT01157455
|Contact: Bo Liu||010-84094934 ext firstname.lastname@example.org|
|Contact: Yuejin Yang email@example.com|
|Contact: Bo Xu firstname.lastname@example.org|
|Principal Investigator:||Yuejin Yang||Fuwai Hospital|