Clinical trial NCT00927940: RESOLUTE Japan - The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent
Official title: The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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)
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
Collaborators: name: Medtronic Japan Co., Ltd.
First posted: 2009-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: In-stent Late Lumen Loss (LLL)
timeFrame: Post procedure, 8 Months
Secondary outcomes:
measure: Percent of Patient With Target Lesion Failure(Major Secondary Endpoint)
timeFrame: 12 months
measure: Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis
timeFrame: 12 months
measure: Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO)
timeFrame: 8 months
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Toyohashi Heart Center
city: Hokkaido
country: Japan
facility: Hospital Hakodate Hokkaido
city: Hyogo
country: Japan
facility: Kansai Rosai Hospital
city: Kanagawa
country: Japan
facility: Kanto Rosai Hospital
city: Kanagawa
country: Japan
facility: Yokohama Tobu Hospital
city: Kanagawa
country: Japan
facility: Shonan Kamakura General Hospital
city: Kumamoto
country: Japan
facility: Kumamoto Rosai Hospital
city: Kyoto
country: Japan
facility: Kyoto Katsura Hospital
city: Okayama
country: Japan
facility: Kurashiki Central Hospital
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital
city: Tokyo
country: Japan
facility: The Cardiovascular Institute Hospital
city: Tokyo
country: Japan
facility: Showa University Hospita
city: Tokyo
country: Japan
facility: Toho University Medical Center, Ohashi Hospital
city: Tokyo
country: Japan
facility: Teikyo University Hospital
Study officials:
affiliation: Shonan Kamakura General Hospital
name: Shigeru Saito, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.