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Status unknownNCT01157455SEEDSUpdated Jul 12, 2010

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

A Phase 4 interventional study of Everolimus Drug Eluting Stent and Aspirin in Coronary Artery Diseases, sponsored by CCRF Consulting Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-07-12.

Sponsored by CCRF Consulting Co., Ltd. · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
1,900
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Coronary Artery Diseases

Keywords

  • Stent
  • Coronary artery diseases
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 1,900 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

CCRF Consulting Co., Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,900 participants (estimated)

Interventions

  • ProcedureEverolimus Drug Eluting Stent

    Implantation

    Also known as: XIENCE(TM) V EECSS, XIENCE(TM) V stent system

  • DrugAspirin

    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

  • DrugClopidogrel

    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.

  • DrugHeparin or Bivalirudin

    During procedure or in-hospital, Heparin 100u/kg or Bivalirudin may be given,or follow up the standard practice of each site.

06

What researchers measure

Primary outcomes

  1. TVF

    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.

    Time frame: 12 months post-index procedure.

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Zhang YJ, Zhao YL, Xu B, Han YL, Li B, Liu Q, Su X, Pang S, Lu SZ, Guo XF, Yang YJ. Clinical impact of dual antiplatelet therapy use in patients following everolimus-eluting stent implantation: insights from the SEEDS study. Chin Med J (Engl). 2015 Mar 20;128(6):714-20. doi: 10.4103/0366-6999.152458. PubMed 25758261 ↗
  • Xu B, Yang YJ, Han YL, Lu SZ, Li B, Liu Q, Zhu GY, Cui JY, Li L, Zhao YL, Kirtane AJ; SEEDS Investigators. Validation of residual SYNTAX score with second-generation drug-eluting stents: one-year results from the prospective multicentre SEEDS study. EuroIntervention. 2014 May;10(1):65-73. doi: 10.4244/EIJV10I1A12. PubMed 24603020 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01157455
Lead sponsor
CCRF Consulting Co., Ltd.
First posted
Jul 7, 2010
Start date
May 2010
Primary completion
Mar 2012 (estimated)
Completion
Jun 2013 (estimated)
Last update
Jul 12, 2010

Study contacts

Bo Liu
Contact
bliu@ccrfmed.com
010-84094934 ext. 816
Yuejin Yang
principal investigator · Chinese Academy of Medical Sciences, Fuwai Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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