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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
Sponsor:
Information provided by:
CCRF Consulting Co., Ltd.

Tracking Information
First Submitted Date  ICMJE July 5, 2010
First Posted Date  ICMJE July 7, 2010
Last Update Posted Date July 12, 2010
Study Start Date  ICMJE May 2010
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01157455 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Registry To Evaluate Safety And Effectiveness Of Everolimus Drug Eluting Stent For Coronary Revascularization
Official Title  ICMJE Clinical Trial Program of a Medical Instrument Product
Brief Summary This is a prospective, multi-center registry to evaluate safety and effectiveness of the Everolimus Drug Eluting Stent for treatment coronary revascularization in Chinese patients with long lesion, small vessel or multi-vessel diseases.
Detailed Description Study Device:The XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V EECSS or XIENCE V stent system) is a device/drug combination product consisting of either the MULTI-LINK VISION® Coronary Stent System or the MULTI-LINK MINI VISION® Coronary Stent System coated with a formulation containing everolimus, the active ingredient, embedded in a non-erodible polymer. Design:A prospective, multi-center, registry that is designed to enroll Chinese patients with either Long Lesion, or Small Vessel or Multi-Vessel diseases. Purpose:To evaluate the safety and effectiveness of the XIENCE V® everolimus drug eluting stent for coronary revascularization of patients with either long lesion, or small vessel, or multi-vessel diseases. Enrollment:Approximately 1900 patients will be enrolled in at least 45 but up to 51 centers. Mainland China 41 up to 47 centers, Taiwan China 3 centers and Macao China 1 center. This registry is planned to enroll at least 50% of patients with multi-vessel disease. Primary Endpoint: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) at 12 months post-index procedure. Follow-Up Visits:30 days, 6 months, 12 months, and 24 months post index procedure.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Diseases
Intervention  ICMJE
  • Procedure: Everolimus Drug Eluting Stent
    Implantation
    Other Names:
    • 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.
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 6, 2010)
1900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2013
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The patient must be ≥18 of age; male or (non-pregnant and non-breast feeding) female.
  2. Diagnosis of stable angina, unstable angina or silent ischemia (evidence of myocardial ischemia).
  3. Target lesion is at least length ≥ 25mm (visual estimate); or the number of target lesion is ≥ 2; or target vessel diameter ≤ 2.75mm.
  4. At least one target lesion with a diameter stenosis ≥70% (visual estimate)
  5. Acceptable candidate for CABG;
  6. The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written Notice of Informed Consent, appropriate Ethics Committee(EC); and the patient is willing to comply with specified follow-up evaluations.

Exclusion Criteria:

  1. Patients have evidence of an Acute Myocardial Infarction within a week prior to the index procedure.
  2. Patient has congenital heart disease, severe valve dysfunction, bridge vascular disease, severe heart failure (NYHA ≥ Ⅲ level), or left ventricular ejection fraction ≤ 30%.
  3. Patient has undergone previous stenting anywhere within the previous 1 year.
  4. Patient has a preoperative renal dysfunction: serum creatinine> 2.0mg/dl (176.82umol / L).
  5. Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated or in which patient will not be able to comply with dual antiplatelet therapy for at least 1 year;
  6. Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, Prasugrel, stainless steel alloy, cobalt chromium, rapamycin, styrene-butylene-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately premedicated; Patient is allergic to contrast agent Sirolimus.
  7. Patient has other medical illness (e.g., cancer, known malignancy , congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy is less than 12 months.
  8. Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up
  9. Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study; Patient has poor compliance with the judgment of the investigator and can not complete the study as required.
  10. Patient who had heart transplant.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01157455
Other Study ID Numbers  ICMJE SEEDS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bo Liu, CCRF
Study Sponsor  ICMJE CCRF Consulting Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yuejin Yang Fuwai Hospital
PRS Account CCRF Consulting Co., Ltd.
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP