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Completed

NCT Number: NCT00927940

RESOLUTE Japan - The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent

The objective of the study is to verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent for the treatment of de novo lesions in native coronary arteries.

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Key information

Conditions

Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toyohashi Heart Center, Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
  • Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
  • Informed consent
  • Patient agrees to comply with specified follow-up evaluations at same investigational site
  • Single target lesion or two target lesions located in separate coronary arteries
  • De novo lesion(s) in native coronary artery(ies)
  • Target lesion(s) ≤ 27 mm in length
  • Target vessel(s) have reference vessel diameter 2.5 mm to 3.5 mm

Exclusion criteria

  • Within 7 days of implant platelet count <100,000 cells/mm³ or >700,000 cells/mm³; white blood cell (WBC) count <3,000 cells/mm³; serum creatinine level >2.5 mg/dl
  • Acute myocadial infarction (MI) within 72 hrs of the index procedure (Q wave myocardial infarction(QWMI) or any elevation of Creatinine Kinase Mycocardial-band Isoemzyme (CK-MB) > lab upper limit of normal)
  • Previous PCI of target vessel(s) within 9 months prior to the procedure
  • Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
  • History of stroke or transient ischemic attack (TIA) within prior 6 months
  • Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
  • Inability to comply with required trial antiplatelet regimen
  • Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
  • Target vessel(s) has/have other lesions w/ > 40% diameter stenosis
  • Unprotected left main coronary artery disease

Treatment and study plan

MDT-4107 Drug Eluting Stent

Device

Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent

Other names: Zotarolimus Eluting Coronary Stent

Primary outcomes

  1. In-stent Late Lumen Loss (LLL)

    Time frame: Post procedure, 8 Months

    The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD

Secondary outcomes

  1. Percent of Patient With Target Lesion Failure(Major Secondary Endpoint)

    Time frame: 12 months

    Major Secondary Endpoint Target lesion fature (TLF) is defined as cardiac death, target vessel myocardial infarction(Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods.

  2. Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis

    Time frame: 12 months

  3. Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO)

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Collaborators

  • Medtronic Japan Co., Ltd.

Registry information

Official study title

The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries

Acronym: RJ

Important dates

Study start
2009
Primary completion
2010
Study completion
2015
First posted
Jun 25, 2009
Registry last updated
May 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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