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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic Japan Co., Ltd.
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00927940
First received: June 23, 2009
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Arterial Occlusive Diseases
Myocardial Ischemia
Cardiovascular Diseases
Coronary Artery Disease
Device: MDT-4107 Drug Eluting Stent

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • In-stent Late Lumen Loss (LLL) [ Time Frame: Post procedure, 8 Months ] [ Designated as safety issue: Yes ]
    The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD


Secondary Outcome Measures:
  • Percent of Patient With Target Lesion Failure(Major Secondary Endpoint) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.

  • Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO) [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: March 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug Eluting Stent
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
Device: MDT-4107 Drug Eluting Stent
Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
Other Name: Zotarolimus Eluting Coronary Stent

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927940

Locations
Japan
Toyohashi Heart Center
Aichi, Japan, 441-8530
Hospital Hakodate Hokkaido
Hokkaido, Japan, 041-8680
Kansai Rosai Hospital
Hyogo, Japan, 660-8511
Shonan Kamakura General Hospital
Kanagawa, Japan, 247-8533
Yokohama Tobu Hospital
Kanagawa, Japan, 230-0012
Kanto Rosai Hospital
Kanagawa, Japan, 211-8510
Kumamoto Rosai Hospital
Kumamoto, Japan, 866-8533
Kyoto Katsura Hospital
Kyoto, Japan, 615-8256
Kurashiki Central Hospital
Okayama, Japan, 710-8602
Jichi Medical University Hospital
Tochigi, Japan, 329-0498
Toho University Medical Center, Ohashi Hospital
Tokyo, Japan, 153-6181
Teikyo University Hospital
Tokyo, Japan, 173-8606
Showa University Hospita
Tokyo, Japan, 142-8666
The Cardiovascular Institute Hospital
Tokyo, Japan, 106-0032
Sponsors and Collaborators
Medtronic Vascular
Medtronic Japan Co., Ltd.
Investigators
Principal Investigator: Shigeru Saito, MD Shonan Kamakura General Hospital
  More Information

Additional Information:
No publications provided by Medtronic Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00927940     History of Changes
Other Study ID Numbers: MDT2-07-03
Study First Received: June 23, 2009
Results First Received: February 9, 2012
Last Updated: May 6, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Medtronic Vascular:
TARGET VESSEL REVASCULARIZATION (TVR)
MYOCARDIAL INFARCTION (MI)
TARGET VESSEL FAILURE (TVF)
TARGET LESION REVASCULARIZATION (TLR)
TARGET LESION FAILURE (TLF)
STENT THROMBOSIS
RESTENOTIC LESION
PERCUTANEOUS CORONARY INTERVENTION (PCI)

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Vascular Diseases
Heart Diseases
Arteriosclerosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014