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Coronary Artery DiseasesPhase 4SEEDSNCT01157455

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

A Phase 4 study testing Everolimus Drug Eluting Stent, Aspirin and Clopidogrel in people with Coronary Artery Diseases, run by CCRF Consulting Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coronary Artery Diseases
What is being tested?
Everolimus Drug Eluting Stent, Aspirin and Clopidogrel
How many people
1,900 participants
Where
1 siteChina
Study dates
May 2010to Jun 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Bo Liu contact

010-84094934 ext. 816

bliu@ccrfmed.com

China1 site, 1 recruiting

  • Fuwai Hospital

    Beijing

    Yuejin Yang, yangyjfw@yahoo.com.cn

    Bo Xu, xubofuwai@gmail.com

    Recruiting

Other trials in China

About this study

Official title: Clinical Trial Program of a Medical Instrument Product

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.

Being tested
Everolimus Drug Eluting Stent, Aspirin, Clopidogrel, Heparin or Bivalirudin
Keywords
Stent, Coronary artery diseases
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Everolimus Drug Eluting StentProcedure or surgery

    Also called XIENCE(TM) V EECSS, XIENCE(TM) V stent system

    Implantation

  • AspirinDrug

    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

  • ClopidogrelDrug

    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.

  • Heparin or BivalirudinDrug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months post-index procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionMar 2012 (estimated)
  4. Study completionJun 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01157455
Sponsor's protocol ID
SEEDS
Acronym
SEEDS
Status last verified
Apr 2010
First submitted
5 Jul 2010
Last updated
12 Jul 2010
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Everolimus Drug Eluting Stent, Aspirin and Clopidogrel in people with Coronary Artery Diseases, run by CCRF Consulting Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bo Liu (010-84094934 ext. 816, bliu@ccrfmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TVF (time frame: 12 months post-index procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01157455, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2010.

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