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

Coronary Artery Disease Clinical Trial

— RJ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927940
• Other study ID #: MDT2-07-03
• Status: Completed
• Phase: N/A
• First received: June 23, 2009
• Last updated: April 14, 2015
• Start date: March 2009
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2015
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• MDT-4107 Drug Eluting Stent
Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent

Locations

Country	Name	City	State
Japan	Toyohashi Heart Center	Aichi
Japan	Hospital Hakodate Hokkaido	Hokkaido
Japan	Kansai Rosai Hospital	Hyogo
Japan	Kanto Rosai Hospital	Kanagawa
Japan	Shonan Kamakura General Hospital	Kanagawa
Japan	Yokohama Tobu Hospital	Kanagawa
Japan	Kumamoto Rosai Hospital	Kumamoto
Japan	Kyoto Katsura Hospital	Kyoto
Japan	Kurashiki Central Hospital	Okayama
Japan	Jichi Medical University Hospital	Tochigi
Japan	Showa University Hospita	Tokyo
Japan	Teikyo University Hospital	Tokyo
Japan	The Cardiovascular Institute Hospital	Tokyo
Japan	Toho University Medical Center, Ohashi Hospital	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Vascular	Medtronic Japan Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent Late Lumen Loss (LLL)	The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD	Post procedure, 8 Months	Yes
Secondary	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.	12 months	Yes
Secondary	Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis		12 months	Yes
Secondary	Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO)		8 months	No

External Links

•   Medtronic Clinical Trials Link
•   Medtronic Japan Home Page