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A Registry To Evaluate Safety And Effectiveness Of Everolimus Drug Eluting Stent For Coronary Revascularization (SEEDS)

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

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Diseases Procedure: Everolimus Drug Eluting Stent Drug: Aspirin Drug: Clopidogrel Drug: Heparin or Bivalirudin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1900 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Intervention Details:
  • Procedure: Everolimus Drug Eluting Stent
    Other Names:
    • 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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01157455

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Contact: Bo Liu 010-84094934 ext 816

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Fuwai Hospital Recruiting
Beijing, China
Contact: Yuejin Yang   
Contact: Bo Xu   
Sponsors and Collaborators
CCRF Consulting Co., Ltd.
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Principal Investigator: Yuejin Yang Fuwai Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bo Liu, CCRF Identifier: NCT01157455    
Other Study ID Numbers: SEEDS
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: July 12, 2010
Last Verified: April 2010
Keywords provided by CCRF Consulting Co., Ltd.:
Coronary artery diseases
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents
Immunosuppressive Agents