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

NCT01157455 | Unknown Phase 4 DMC

• 1 other identifier: SEEDS
• Study Type: interventional
• Target: 1,900
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Diseases

Keywords

Stent; Coronary artery diseases

Outcome Measures

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.

  12 months post-index procedure.

Interventions

Everolimus Drug Eluting Stent PROCEDURE

Implantation

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

Aspirin DRUG

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

Clopidogrel DRUG

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 Bivalirudin DRUG

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• CCRF Consulting Co., Ltd.: lead

Study Sites (1)

Fuwai Hospital

Beijing, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 25758261 DERIVED

• 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.

  PMID: 24603020 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin; Clopidogrel; Heparin; bivalirudin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Yuejin Yang

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Liu

CONTACT

010-84094934; bliu@ccrfmed.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2010
• First Posted: July 7, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2013
• Last Updated: July 12, 2010

Record last verified: 2010-04

Locations

CN (1)