Clinical trial NCT01670318: Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets
Official title: Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Chronic total occlusion
Bifurcation lesion
Left main trunk lesion
Small vessel disease
Multi vessel disease
Lead sponsor: The PCI Guideline Research Society
Sponsor class: NETWORK
First posted: 2012-08-22
Enrollment: 800
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Randomized trials have demonstrated an excellent safety and efficacy profile for the chromium everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES) uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. However, the efficacy of the PtCr-EES for complex coronary artery diseases subsets such as chronic total occlusion, bifurcation lesion, left main trunk disease, and small vessel diseases is still unknown.


Eligibility criteria: Inclusion Criteria:

1. A patient with ischemic heart disease including stable angina pectoris and acute coronary syndrome
2. Male or non-pregnant female
3. Key lesion inclusion criteria as follows

   1. Multi-vessel diseases
   2. Long lesion (lesion length \>30mm by visual estimation)
   3. Small vessel disease (reference diameter \<2.5mm by visual estimation)
   4. Bifurcation lesion
   5. Ostial lesion
   6. Calcified lesion
   7. Protected or non-protected left main trunk disease
   8. Chronic total occlusion
   9. In stent restenosis of bare metal stent or everolimus-eluting stent

Exclusion Criteria:

1. Hypersensitivity to cobalt chromium, everolimus, heparin, aspirin, ticlopidine, clopidogrel or X-ray contrast media.
2. Serum creatinine level \>3.0 mg/dL
3. Other concomitant disease or medical condition that could impact patient/procedural outcomes, such as history of bleeding diathesis or cancer within 5 years.

Primary outcomes:
measure: Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization
timeFrame: 12 month
Secondary outcomes:
measure: Successful stent delivery with final percent diameter stenosis less than 50% at minimum lumen diameter site
timeFrame: In hospital
measure: Target lesion revascularization
timeFrame: 12 month
measure: Target vessel revascularization
timeFrame: 12 month
measure: Myocardial infarction
timeFrame: 24 month
measure: Cardiac death
timeFrame: 24 month
measure: Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization
timeFrame: 24 month
measure: Stent thrombosis (acute, sub-acute, late,and very late) defined by Academic Research Consortium (ARC)
timeFrame: 24 month
Other outcomes:
Locations:
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
state: Aichi
city: Toyohashi
country: Japan
facility: Toyohashi Heart Center
state: Aichi
city: Urayasu
country: Japan
facility: Juntendo University Urayasu Hospital
state: Chiba
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Koriyama
country: Japan
facility: Hoshi General Hospital
state: Fukushima
city: Koriyama
country: Japan
facility: Southern Tohoku Research Institute for Neuroscience
state: Fukushima
city: Maebashi
country: Japan
facility: Gunma Prefectural Cardiovascular Center
state: Gunma
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Ota
country: Japan
facility: Ota Memorial Hospital
state: Gunma
city: Eniwa
country: Japan
facility: Megumino Hospital
state: Hokkaido
city: Monbetsu
country: Japan
facility: JA Hokkaido Engaru Kosei General Hospital
state: Hokkaido
city: Nayoro
country: Japan
facility: Nayoro City General Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Cardio Vascular Clinic
state: Hokkaido
city: Amagasaki
country: Japan
facility: Kansai Rosai Hospital
state: Hyogo
city: Kakogawa
country: Japan
facility: Kakogawa East City Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Tsukuba
country: Japan
facility: Tsukuba Medical Center Hospital
state: Ibaragi
city: Yokohama
country: Japan
facility: Yokohama Rosai Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City Minato Red Cross Hospital
state: Kanagawa
city: Uji
country: Japan
facility: Daini Okamoto General Hospital
state: Kyoto
city: Matsumoto
country: Japan
facility: Matsumoto Kyoritsu Hospital
state: Nagano
city: Izumisano
country: Japan
facility: Rinku General Medical Center
state: Osaka
city: Takatsuki
country: Japan
facility: Hokusetsu General Hospital
state: Osaka
city: Kasukabe
country: Japan
facility: SHUWA General Hospital
state: Saitama
city: Kasukabe
country: Japan
facility: Kasukabe Chuo General Hospital
state: Saitama
city: Toda
country: Japan
facility: TODA CHUO General Hospital
state: Saitama
city: Hamamatsu
country: Japan
facility: Seirei Mikatahara General Hospital
state: Shizuoka
city: Adachi-ku
country: Japan
facility: Ayase Heart Hospital
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Tokyo Rinkai Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Itabashi Chuo Medical Center
state: Tokyo
city: Katsushika-ku
country: Japan
facility: Katsushika Medical Center
state: Tokyo
city: Kita-ku
country: Japan
facility: Tokyo-Kita Social Insurance Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: The Cardiovascular Institute
state: Tokyo
city: Nakano-ku
country: Japan
facility: Tokyo Metropolitan Police Hospital
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Tokyo Metropolitan Hiroo Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo
state: Tokyo
city: Fukuoka
country: Japan
facility: Saiseikai Fukuoka General Hospital
city: Kumamoto
country: Japan
facility: Saiseikai Kumamoto Hospital
Study officials:
affiliation: The Cardiovascular Institute
name: Yuji Oikawa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toyohashi Heart Center
name: Kenya Nasu, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References: