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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by CCRF Consulting Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
CCRF Consulting Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01157455
First received: July 5, 2010
Last updated: July 8, 2010
Last verified: April 2010
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial Program of a Medical Instrument Product

Resource links provided by NLM:


Further study details as provided by CCRF Consulting Co., Ltd.:

Primary Outcome Measures:
  • TVF [ Time Frame: 12 months post-index procedure. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1900
Study Start Date: May 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157455

Contacts
Contact: Bo Liu 010-84094934 ext 816 bliu@ccrfmed.com

Locations
China
Fuwai Hospital Recruiting
Beijing, China
Contact: Yuejin Yang       yangyjfw@yahoo.com.cn   
Contact: Bo Xu       xubofuwai@gmail.com   
Sponsors and Collaborators
CCRF Consulting Co., Ltd.
Investigators
Principal Investigator: Yuejin Yang Fuwai Hospital
  More Information

No publications provided by CCRF Consulting Co., Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bo Liu, CCRF
ClinicalTrials.gov Identifier: NCT01157455     History of Changes
Other Study ID Numbers: SEEDS
Study First Received: July 5, 2010
Last Updated: July 8, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by CCRF Consulting Co., Ltd.:
Stent
Coronary artery diseases

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Heparin
Clopidogrel
Bivalirudin
Everolimus
Sirolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014