Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets
SPECIALIST
1 other identifier
interventional
800
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Aug 2012
Typical duration for not_applicable coronary-artery-disease
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 16, 2012
CompletedFirst Posted
Study publicly available on registry
August 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedAugust 22, 2012
August 1, 2012
1.3 years
August 16, 2012
August 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization
12 month
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (1)
platinum chromium everolimus-eluting stent
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- A patient with ischemic heart disease including stable angina pectoris and acute coronary syndrome
- Male or non-pregnant female
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Aichi Medical University Hospital
Nagakute, Aichi-ken, 480-1195, Japan
Toyohashi Heart Center
Toyohashi, Aichi-ken, 441-8530, Japan
Juntendo University Urayasu Hospital
Urayasu, Chiba, 279-0021, Japan
Saiseikai Fukuoka General Hospital
Fukuoka, Fukuoka, 810-0001, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555, Japan
Hoshi General Hospital
Kōriyama, Fukushima, 963-8501, Japan
Southern Tohoku Research Institute for Neuroscience
Kōriyama, Fukushima, 963-8563, Japan
Gunma Prefectural Cardiovascular Center
Maebashi, Gunma, 371-0004, Japan
Gunma University Hospital
Maebashi, Gunma, 371-8511, Japan
Ota Memorial Hospital
Ōta, Gunma, 373-8585, Japan
Megumino Hospital
Eniwa, Hokkaido, 061-1395, Japan
JA Hokkaido Engaru Kosei General Hospital
Monbetsu, Hokkaido, 099-0404, Japan
Nayoro City General Hospital
Nayoro, Hokkaido, 096-8511, Japan
Sapporo Cardio Vascular Clinic
Sapporo, Hokkaido, 007-0849, Japan
Kansai Rosai Hospital
Amagasaki, Hyōgo, 660-8511, Japan
Kakogawa East City Hospital
Kakogawa, Hyōgo, 685-0115, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Tsukuba Medical Center Hospital
Tsukuba, Ibaragi, 305-8558, Japan
Yokohama Rosai Hospital
Yokohama, Kanagawa, 222-0036, Japan
Yokohama City Minato Red Cross Hospital
Yokohama, Kanagawa, 231-8682, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, 861-4193, Japan
Daini Okamoto General Hospital
Uji, Kyoto, 611-0025, Japan
Matsumoto Kyoritsu Hospital
Matsumoto, Nagano, 390-8505, Japan
Rinku General Medical Center
Izumisano, Osaka, 598-8577, Japan
Hokusetsu General Hospital
Takatsuki, Osaka, 569-0852, Japan
SHUWA General Hospital
Kasukabe, Saitama, 344-0035, Japan
Kasukabe Chuo General Hospital
Kasukabe, Saitama, 344-0063, Japan
TODA CHUO General Hospital
Toda, Saitama, 335-0023, Japan
Seirei Mikatahara General Hospital
Hamamatsu, Shizuoka, 433-8558, Japan
Ayase Heart Hospital
Adachi-ku, Tokyo, 120-0006, Japan
Tokyo Rinkai Hospital
Edogawa-ku, Tokyo, 134-0086, Japan
Itabashi Chuo Medical Center
Itabashi-ku, Tokyo, 174-0051, Japan
Katsushika Medical Center
Katsushika-ku, Tokyo, 125-8506, Japan
Tokyo-Kita Social Insurance Hospital
Kita-ku, Tokyo, 115-0053, Japan
The Cardiovascular Institute
Minato-ku, Tokyo, 106-0031, Japan
Tokyo Metropolitan Police Hospital
Nakano-ku, Tokyo, 164-8541, Japan
Tokyo Metropolitan Hiroo Hospital
Shibuya-ku, Tokyo, 150-0013, Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, 141-8625, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuji Oikawa, MD, PhD
The Cardiovascular Institute
- PRINCIPAL INVESTIGATOR
Kenya Nasu, MD, FACC
Toyohashi Heart Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2012
First Posted
August 22, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2015
Last Updated
August 22, 2012
Record last verified: 2012-08