A non-randomized, small vessel (SV) trial at approximately 15 sites in Japan to enroll 60 patients with a de novo lesion ≤28 mm in length (by visual estimate) in a native coronary artery ≥2.25 mm to \<2.50 mm in diameter (by visual estimate). Approximately thirty patients will be randomly assigned to the angiographic subset to also undergo angiographic assessment after the 12-month clinical follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
PROMUS Element Everolimus-Eluting Coronary Stent System
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, Japan
Hoshi General Hospital
Koriyama-shi, Fukushima, Japan
Hakodate Municipal Hospital
Hakodate-shi, Hokkaido, Japan
Major Adverse Cardiac Events (MACE) (Percentage of Participants With an Event)
A major adverse cardiac event (MACE) is defined as any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI, Q-wave and non-Q-wave), or cardiac death. Reported as percentage of participants who have experienced a MACE event.
Time frame: 9 months
Myocardial Infarction (MI) (Percentage of Participants With an Event)
New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase- myoglobin band (CK-MB) or troponin above upper limit of normal (ULN) (baseline troponin \<ULN); if no new Q-waves total CK or troponin \>3× ULN (baseline troponin \<ULN) plus at least one of the following: electrocardiogram changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin \>5× ULN
Time frame: 9 months
All-cause Death (Percentage of Participants With an Event)
Participants who died from any cause
Time frame: 9 months
Cardiac Death (Percentage of Participants With an Event)
Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded. Reported as percentage of participants who experienced cardiac death.
Time frame: 9 months
Target Vessel Revascularization (Percentage of Participants With an Event)
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Hokkaido Social Insurance Hospital
Sapporo, Hokkaido, Japan
Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa, Japan
Japan Labour Health and Welfare Organization Kanto Rosai Hospital
Kawasaki-shi, Kanagawa, Japan
Saiseikai Yokohama-City Eastern Hospital
Yokohama, Kanagawa, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Japan Labour Health and Welfare Organization Kumamoto Rosai Hospital
Yatsushiro-shi, Kumamoto, Japan
Kyoto-Katsura Hospital
Kyoto, Kyoto, Japan
...and 5 more locations
Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.Reported as percentage of participants who experienced a TVR.
Time frame: 9 months
Target Lesion Revascularization (Percentage of Participants With an Event)
Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. Reported as percentage of participants who experienced a TLR.
Time frame: 9 months
Target Vessel Failure (TVF) (Percentage of Participants With an Event)
Includes any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. Reported as percentage of participants who experienced a TVF event.
Time frame: 9 months
Target Lesion Failure (TLF) (Percentage of Participants With an Event)
Target lesion failure (TLF) is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. Reported as percentage of participants who experienced a TLF event.
Time frame: 9 months
Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event)
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \>24 hours to 30 days post; late ST: \>30 days to 1 year post; Very late ST: \>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)
Time frame: 0-30 Days (Early)
Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event)
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \>24 hours to 30 days post; late ST: \>30 days to 1 year post; Very late ST: \>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)
Time frame: >30 days - 9 months
Technical Success (Percentage of Stents)
Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent
Time frame: At time of index procedure
Clinical Procedural Success (Percentage of Participants)
Expressed as percentage of participants in whom mean lesion diameter stenosis was \<30% with TIMI 3 flow (visually assessed) and who did not experience an occurrence of in-hospital myocardial infarction, target vessel revascularization, or cardiac death.
Time frame: While participant is in the hospital