Clinical trial NCT01150500: RESOLUTE Japan SVS: The Clinical Evaluation of the MDT-4107 DES in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries
Official title: RESOLUTE JAPAN SVS: The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Occlusive Diseases
Myocardial Ischemia
Cardiovascular Diseases
Coronary Artery Disease
Keywords: Medtronic
Japan
Arterial Occlusive Diseases
Myocardial Ischemia
Cardiovascular Diseases
Coronary Artery Disease
Small Vessel Stent
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2010-06-25
Enrollment: 65
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 in the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows the use of 2.25mm diameter stents.

Detailed description: The objective of the study is to verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent in the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows the use of 2.25mm diameter stents.

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 2.25 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 myocardial infarction (MI) within 72 hrs of the index procedure (Q wave myocardial infarction(QWMI)/non Q wave myocardial infarction (NQMI) or any elevation of creatinine kinease myocardial-band isoenzyme(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: Target Lesion Failure(TLF)
timeFrame: 9 month
Secondary outcomes:
measure: MACE (Major Adverse Cardiac Event)
timeFrame: Baseline and 9 month
measure: Late Lumen Loss
timeFrame: Baseline and 9 months
measure: Binary Angiographic Restenosis
timeFrame: Baseline and 9 month
measure: Minimum Luminal Diameter
timeFrame: 9 month
measure: Percent Diameter Stenosis
timeFrame: Baseline and 9 month
measure: Clinical Endpoints
timeFrame: 5 Years
Other outcomes:
Locations:
city: Kanagawa
country: Japan
facility: Shonan Kamakura General Hospital
Study officials:
affiliation: Sohana Kamakura General Hosptial
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.