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
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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 |
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 |

- Procedure: Everolimus Drug Eluting Stent
ImplantationOther 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.
- 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.

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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:
- The patient must be ≥18 of age; male or (non-pregnant and non-breast feeding) female.
- Diagnosis of stable angina, unstable angina or silent ischemia (evidence of myocardial ischemia).
- Target lesion is at least length ≥ 25mm (visual estimate); or the number of target lesion is ≥ 2; or target vessel diameter ≤ 2.75mm.
- At least one target lesion with a diameter stenosis ≥70% (visual estimate)
- Acceptable candidate for CABG;
- 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:
- Patients have evidence of an Acute Myocardial Infarction within a week prior to the index procedure.
- Patient has congenital heart disease, severe valve dysfunction, bridge vascular disease, severe heart failure (NYHA ≥ Ⅲ level), or left ventricular ejection fraction ≤ 30%.
- Patient has undergone previous stenting anywhere within the previous 1 year.
- Patient has a preoperative renal dysfunction: serum creatinine> 2.0mg/dl (176.82umol / L).
- 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;
- 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.
- 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.
- Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up
- 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.
- Patient who had heart transplant.

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 816 | bliu@ccrfmed.com |
China | |
Fuwai Hospital | Recruiting |
Beijing, China | |
Contact: Yuejin Yang yangyjfw@yahoo.com.cn | |
Contact: Bo Xu xubofuwai@gmail.com |
Principal Investigator: | Yuejin Yang | Fuwai Hospital |
Responsible Party: | Bo Liu, CCRF |
ClinicalTrials.gov 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 |
Stent Coronary artery diseases |
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Aspirin Everolimus Heparin Bivalirudin Clopidogrel Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics 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 Antipyretics Antineoplastic Agents Immunosuppressive Agents |