RESOLUTE Japan - The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent (RJ)
This study is ongoing, but not recruiting participants.
Sponsor:
Medtronic Vascular
Collaborator:
Medtronic Japan Co., Ltd.
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00927940
First received: June 23, 2009
Last updated: April 17, 2013
Last verified: April 2013
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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
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
| 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: | April 17, 2013 |
| 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 May 16, 2013