Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets
- Conditions
- Coronary Artery Disease
- Interventions
- Device: platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)
- Registration Number
- NCT01670318
- Lead Sponsor
- The PCI Guideline Research Society
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 800
-
A patient with ischemic heart disease including stable angina pectoris and acute coronary syndrome
-
Male or non-pregnant female
-
Key lesion inclusion criteria as follows
- Multi-vessel diseases
- Long lesion (lesion length >30mm by visual estimation)
- Small vessel disease (reference diameter <2.5mm by visual estimation)
- Bifurcation lesion
- Ostial lesion
- Calcified lesion
- Protected or non-protected left main trunk disease
- Chronic total occlusion
- In stent restenosis of bare metal stent or everolimus-eluting stent
- Hypersensitivity to cobalt chromium, everolimus, heparin, aspirin, ticlopidine, clopidogrel or X-ray contrast media.
- Serum creatinine level >3.0 mg/dL
- Other concomitant disease or medical condition that could impact patient/procedural outcomes, such as history of bleeding diathesis or cancer within 5 years.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description platinum chromium everolimus-eluting stent platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts) -
- Primary Outcome Measures
Name Time Method Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization 12 month
- Secondary Outcome Measures
Name Time Method Successful stent delivery with final percent diameter stenosis less than 50% at minimum lumen diameter site In hospital Target lesion revascularization 12 month Target vessel revascularization 12 month Myocardial infarction 24 month Cardiac death 24 month Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization 24 month Stent thrombosis (acute, sub-acute, late,and very late) defined by Academic Research Consortium (ARC) 24 month
Trial Locations
- Locations (38)
Ayase Heart Hospital
🇯🇵Adachi-ku, Tokyo, Japan
Itabashi Chuo Medical Center
🇯🇵Itabashi-ku, Tokyo, Japan
Tokyo-Kita Social Insurance Hospital
🇯🇵Kita-ku, Tokyo, Japan
The Cardiovascular Institute
🇯🇵Minato-ku, Tokyo, Japan
Gunma Prefectural Cardiovascular Center
🇯🇵Maebashi, Gunma, Japan
Rinku General Medical Center
🇯🇵Izumisano, Osaka, Japan
Kasukabe Chuo General Hospital
🇯🇵Kasukabe, Saitama, Japan
Hokusetsu General Hospital
🇯🇵Takatsuki, Osaka, Japan
Gunma University Hospital
🇯🇵Maebashi, Gunma, Japan
Toyohashi Heart Center
🇯🇵Toyohashi, Aichi, Japan
Aichi Medical University Hospital
🇯🇵Nagakute, Aichi, Japan
Yokohama Rosai Hospital
🇯🇵Yokohama, Kanagawa, Japan
Yokohama City Minato Red Cross Hospital
🇯🇵Yokohama, Kanagawa, Japan
Daini Okamoto General Hospital
🇯🇵Uji, Kyoto, Japan
Tokyo Metropolitan Police Hospital
🇯🇵Nakano-ku, Tokyo, Japan
Tokyo Rinkai Hospital
🇯🇵Edogawa-ku, Tokyo, Japan
Katsushika Medical Center
🇯🇵Katsushika-ku, Tokyo, Japan
Tsukuba Medical Center Hospital
🇯🇵Tsukuba, Ibaragi, Japan
Matsumoto Kyoritsu Hospital
🇯🇵Matsumoto, Nagano, Japan
SHUWA General Hospital
🇯🇵Kasukabe, Saitama, Japan
Seirei Mikatahara General Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Saiseikai Kumamoto Hospital
🇯🇵Kumamoto, Japan
Juntendo University Urayasu Hospital
🇯🇵Urayasu, Chiba, Japan
Hoshi General Hospital
🇯🇵Koriyama, Fukushima, Japan
Kokura Memorial Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
Ota Memorial Hospital
🇯🇵Ota, Gunma, Japan
Megumino Hospital
🇯🇵Eniwa, Hokkaido, Japan
Southern Tohoku Research Institute for Neuroscience
🇯🇵Koriyama, Fukushima, Japan
JA Hokkaido Engaru Kosei General Hospital
🇯🇵Monbetsu, Hokkaido, Japan
Nayoro City General Hospital
🇯🇵Nayoro, Hokkaido, Japan
Sapporo Cardio Vascular Clinic
🇯🇵Sapporo, Hokkaido, Japan
Kansai Rosai Hospital
🇯🇵Amagasaki, Hyogo, Japan
Kakogawa East City Hospital
🇯🇵Kakogawa, Hyogo, Japan
Kobe University Hospital
🇯🇵Kobe, Hyogo, Japan
TODA CHUO General Hospital
🇯🇵Toda, Saitama, Japan
Saiseikai Fukuoka General Hospital
🇯🇵Fukuoka, Japan
Tokyo Metropolitan Hiroo Hospital
🇯🇵Shibuya-ku, Tokyo, Japan
NTT Medical Center Tokyo
🇯🇵Shinagawa-ku, Tokyo, Japan