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

Primary Purpose

Arterial Occlusive Diseases, Myocardial Ischemia, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
MDT-4107 Drug Eluting Stent
Sponsored by
Medtronic Vascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Occlusive Diseases focused on measuring 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)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toyohashi Heart Center
  • Hospital Hakodate Hokkaido
  • Kansai Rosai Hospital
  • Kanto Rosai Hospital
  • Yokohama Tobu Hospital
  • Shonan Kamakura General Hospital
  • Kumamoto Rosai Hospital
  • Kyoto Katsura Hospital
  • Kurashiki Central Hospital
  • Jichi Medical University Hospital
  • The Cardiovascular Institute Hospital
  • Showa University Hospita
  • Toho University Medical Center, Ohashi Hospital
  • Teikyo University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug Eluting Stent

Arm Description

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.

Outcomes

Primary Outcome Measures

In-stent Late Lumen Loss (LLL)
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)
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
Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO)

Full Information

First Posted
June 23, 2009
Last Updated
April 14, 2015
Sponsor
Medtronic Vascular
Collaborators
Medtronic Japan Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00927940
Brief Title
RESOLUTE Japan - The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent
Acronym
RJ
Official Title
The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Vascular
Collaborators
Medtronic Japan Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Occlusive Diseases, Myocardial Ischemia, Cardiovascular Diseases, Coronary Artery Disease
Keywords
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug Eluting Stent
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MDT-4107 Drug Eluting Stent
Other Intervention Name(s)
Zotarolimus Eluting Coronary Stent
Intervention Description
Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
Primary Outcome Measure Information:
Title
In-stent Late Lumen Loss (LLL)
Description
The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD
Time Frame
Post procedure, 8 Months
Secondary Outcome Measure Information:
Title
Percent of Patient With Target Lesion Failure(Major Secondary Endpoint)
Description
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.
Time Frame
12 months
Title
Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis
Time Frame
12 months
Title
Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO)
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigeru Saito, MD
Organizational Affiliation
Shonan Kamakura General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toyohashi Heart Center
City
Aichi
ZIP/Postal Code
441-8530
Country
Japan
Facility Name
Hospital Hakodate Hokkaido
City
Hokkaido
ZIP/Postal Code
041-8680
Country
Japan
Facility Name
Kansai Rosai Hospital
City
Hyogo
ZIP/Postal Code
660-8511
Country
Japan
Facility Name
Kanto Rosai Hospital
City
Kanagawa
ZIP/Postal Code
211-8510
Country
Japan
Facility Name
Yokohama Tobu Hospital
City
Kanagawa
ZIP/Postal Code
230-0012
Country
Japan
Facility Name
Shonan Kamakura General Hospital
City
Kanagawa
ZIP/Postal Code
247-8533
Country
Japan
Facility Name
Kumamoto Rosai Hospital
City
Kumamoto
ZIP/Postal Code
866-8533
Country
Japan
Facility Name
Kyoto Katsura Hospital
City
Kyoto
ZIP/Postal Code
615-8256
Country
Japan
Facility Name
Kurashiki Central Hospital
City
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
The Cardiovascular Institute Hospital
City
Tokyo
ZIP/Postal Code
106-0032
Country
Japan
Facility Name
Showa University Hospita
City
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Toho University Medical Center, Ohashi Hospital
City
Tokyo
ZIP/Postal Code
153-6181
Country
Japan
Facility Name
Teikyo University Hospital
City
Tokyo
ZIP/Postal Code
173-8606
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25428602
Citation
Saito S, Maehara A, Vlachojannis GJ, Parise H, Mehran R; RESOLUTE Japan Investigators. Clinical and angiographic evaluation of the resolute zotarolimus-eluting coronary stent in Japanese patients - long-term outcome in the RESOLUTE Japan and RESOLUTE Japan small vessel study. Circ J. 2015;79(1):96-103. doi: 10.1253/circj.CJ-14-0836. Epub 2014 Nov 27.
Results Reference
derived
PubMed Identifier
24510638
Citation
Silber S, Kirtane AJ, Belardi JA, Liu M, Brar S, Rothman M, Windecker S. Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation. Eur Heart J. 2014 Aug 1;35(29):1949-56. doi: 10.1093/eurheartj/ehu026. Epub 2014 Feb 7.
Results Reference
derived
PubMed Identifier
23523454
Citation
Silber S, Serruys PW, Leon MB, Meredith IT, Windecker S, Neumann FJ, Belardi J, Widimsky P, Massaro J, Novack V, Yeung AC, Saito S, Mauri L. Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the international global RESOLUTE program. JACC Cardiovasc Interv. 2013 Apr;6(4):357-68. doi: 10.1016/j.jcin.2012.11.006. Epub 2013 Mar 20.
Results Reference
derived
PubMed Identifier
23468513
Citation
Farooq V, Vranckx P, Mauri L, Cutlip DE, Belardi J, Silber S, Widimsky P, Leon M, Windecker S, Meredith I, Negoita M, van Leeuwen F, Neumann FJ, Yeung AC, Garcia-Garcia HM, Serruys PW. Impact of overlapping newer generation drug-eluting stents on clinical and angiographic outcomes: pooled analysis of five trials from the international Global RESOLUTE Program. Heart. 2013 May;99(9):626-33. doi: 10.1136/heartjnl-2012-303368. Epub 2013 Mar 6.
Results Reference
derived
Links:
URL
http://clinicaltrials.medtronic.com/
Description
Medtronic Clinical Trials Link

Learn more about this trial

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

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